meddevicedb.com FDA Device Reference

Review Panel

General, Plastic Surgery FDA 510(k) Clearances & Devices

Cleared Devices
16,323
Product Codes (page)
41
Latest Decision
1988-06-20

Clearances · page 133 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K881036 HEMO SUC NUMBER HS100-HS205 Instrumental Medico Croquevielle S.A. GCY Class I 1988-06-20
K880061 FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM Abbott Laboratories GEX Class II 1988-06-20
K882037 SHARPLAN MEDILAS 4060 N Sharplan Lasers, Inc. GEX Class II 1988-06-20
K882169 SURGICAL DUCT CLAMP (VINE) Henley Intl. GDJ Class I 1988-06-17
K880480 DUNFORD SURGEON'S STERILE GLOVES Phillippine Radiant C/O U.S. Polymer Industries KGO Class I 1988-06-17
K881378 PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE Pfizer, Inc. LXI Class I 1988-06-17
K882074 SUCTION RETRACTORS Karlin Technology, Inc. GAD Class I 1988-06-16
K882075 SELF-RETAINING SOFT TISSUE RETRACTOR Karlin Technology, Inc. GAD Class I 1988-06-16
K882078 SPINAL SURGERY FRAME Karlin Technology, Inc. FWZ Class I 1988-06-16
K882027 COMBO-SHIELD Bfd, Inc. FXX Class II 1988-06-15
K882166 JEDMED MICRO CCD CAMERA SYSTEM Jedmed Instrument Co. FWD Class I 1988-06-15
K881638 SURGICAL BLADE Far East Intl. Trading Corp. GES Class I 1988-06-15
K882026 ADD-A-SHIELD Bfd, Inc. FXX Class II 1988-06-15
K882112 MURSE RETRACTOR Euro-American Marketing Group, Inc. GAD Class I 1988-06-15
K881937 SURGICAL INSTRUMENTS Far East Intl. Trading Corp. HRQ Class I 1988-06-15
K882013 SOFT TISSUE BIOPSY DEVICE Ocean Medical Products, Ltd. DWO Class I 1988-06-15
K882132 LIGHT, SURGICAL ACCESSORIES Charles Polo & Co., Inc. FTA Class II 1988-06-15
K882028 COVERALL SHIELD Bfd, Inc. FXX Class II 1988-06-15
K882128 TECNOL TIGER PAWS PRODUCT NUMBER 47705-010 Tecnol New Jersey Wound Care, Inc. FXP Class I 1988-06-15
K882008 ACE SCREW REMOVAL TREPHINE Buckman Co., Inc. HWE Class I 1988-06-10
K881583 MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT Laser Engineering, Inc. GEX Class II 1988-06-03
K881581 MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USE Laser Engineering, Inc. GEX Class II 1988-06-03
K881580 MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERY Laser Engineering, Inc. GEX Class II 1988-06-03
K881586 MODEL MD-45 CO2 LASER FOR ENT APPLICATIONS Laser Engineering, Inc. GEX Class II 1988-06-03
K881582 MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE Laser Engineering, Inc. GEX Class II 1988-06-03
K881584 MODEL MD-45 CO2 LASER FOR NEUROSURGERY USE Laser Engineering, Inc. GEX Class II 1988-06-03
K881588 MODEL MD-25 LASER FOR SURGICAL USE Laser Engineering, Inc. GEX Class II 1988-06-03
K881587 MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONS Laser Engineering, Inc. GEX Class II 1988-06-03
K881952 SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI. Sharplan Lasers, Inc. GEX Class II 1988-06-03
K881741 STUART LEE CLIP Stuart-Lee, Inc. GDJ Class I 1988-06-03
K881585 MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE Laser Engineering, Inc. GEX Class II 1988-06-03
K881953 SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU Sharplan Lasers, Inc. GEX Class II 1988-06-03
K882180 MODIFIED SHARPLAN MODEL 1020 CO2 LASER Sharplan Lasers, Inc. GEX Class II 1988-06-02
K881756 STERILE SURGEONS GLOVES Packaging Technologies, Inc. KGO Class I 1988-06-01
K881224 ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE Acufex Microsurgical, Inc. GAE Class I 1988-06-01
K880329 FACTOR II PROSTHETIC SILICONE ELASTOMER Factor, Ii, Inc. GBI Class I 1988-06-01
K881821 STERILE SURGICAL LATEX GLOVE Nca Med Intl./Noble House, Inc. KGO Class I 1988-06-01
K880446 SAFESKIN STERILE SURGEONS GLOVES Safeskin Corp. KGO Class I 1988-06-01
K881870 SHARPLAN ND:YAG SURGICAL HAND APPLICATORS Sharplan Lasers, Inc. GEX Class II 1988-05-24
K881824 LASER MICROMANIPULATOR Pfizer Laser Systems GEX Class II 1988-05-24
K881873 INTRODUCTION/DRAINAGE CATHETER & ACCESS Sheridan Catheter Corp. GBS Class I 1988-05-18
K881910 LABELING CHANGE TO SURGICAL FACE MASK Louis M. Gerson Co., Inc. FXX Class II 1988-05-18
K881887 SHARPLAN 719Y MICROSLAD(TM) Sharplan Lasers, Inc. GEX Class II 1988-05-13
K881730 BREAST LOCALIZATION NEEDLES Hart Enterprises, Inc. GDM Class I 1988-05-13
K880890 THE S.A.F.E. SYSTEM Pfizer Laser Systems FYD Class II 1988-05-11
K881848 MODIFIED MODEL 2100 ND:YAG LASER Sharplan Lasers, Inc. GEX Class II 1988-05-11
K881618 ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK 3M Company FXX Class II 1988-05-09
K881484 BIOFRAGMENTABLE BOWEL ANASTOMOSIS RING Davis & Geck, Inc. GDW Class II 1988-05-04
K881276 HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS Ime Co. , Ltd. KCW Class I 1988-05-04
K880881 ARTUS DISPOSABLE SHEATHS/CUTTERS Acufex Microsurgical, Inc. HSZ Class I 1988-05-04
K881460 SMOKEVAC ELECTORSURGICAL PENCIL Byron Medical GEI Class II 1988-05-04
K880908 MODEL PC ARGON LASER Hgm, Inc. GEX Class II 1988-05-03
K881516 COMPRESAID R. Evans Corp. FZF Class I 1988-04-29
K881398 TOURNIQUET Barretta Products, Research and Development, Inc. GAX Class I 1988-04-29
K881396 OPERATING ROOM TOWELS -STERILE & NON-STERILE A Plus International, Inc. KKX Class II 1988-04-29
K880961 ALCON SURGICAL PROCEDURE PACKS Alcon Laboratories LRO Class II 1988-04-29
K881413 ELECTRO-CAUTERY SUCTION TUBE Alto Development Corp. GEI Class II 1988-04-21
K881359 DECALCIFYING SOLUTION II Stephens Scientific KOX Class I 1988-04-19
K881427 SPIRIX(TM) Medical/Surgical Specialties, Ltd. GEI Class II 1988-04-19
K880863 BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200 New England Surgical Instrument Corp. GEI Class II 1988-04-19
K881409 SUN SHELL (SUN TANNING BED) Indoor Sun Systems, Inc. LEJ Class II 1988-04-19
K881492 MTI WOLFF SYSTEM, TANNING BED Health Systems Intl., Inc. LEJ Class II 1988-04-19
K880809 ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU Cooper Lasersonics, Inc. GEX Class II 1988-04-18
K880807 ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU Cooper Lasersonics, Inc. GEX Class II 1988-04-18
K880808 ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU Cooper Lasersonics, Inc. GEX Class II 1988-04-18
K881250 ACE PNEUMATIC OSCILLATING SAW Buckman Co., Inc. HSZ Class I 1988-04-15
K880193 MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE Sharplan Lasers, Inc. LNK Class II 1988-04-14
K881014 THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM KARL STORZ Endoscopy-America, Inc. FWF Class I 1988-04-14
K881479 OPERATION ROOM TOWEL Rahn Laboratories KKX Class II 1988-04-14
K881406 YESNG REUSABLE ELECTROSURGICAL ELECTRODE Ferguson Medical GEI Class II 1988-04-14
K880256 MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE Sharplan Lasers, Inc. LNK Class II 1988-04-14
K881408 YESNG REUSABLE ELECTROSURGICAL HANDLE Ferguson Medical GEI Class II 1988-04-14
K881407 YESNG RESUABLE BIPOLAR FORCEPS Ferguson Medical GEI Class II 1988-04-14
K875338 CHRYS(TM) MODEL MED-MAX California Laboratories, Inc. GEX Class II 1988-04-13
K875039 ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY Surgilase, Inc. LNK Class II 1988-04-13
K875253 BFGOODRICH BIOTHANE NON-ADHERENT DRESSING The Bfgoodrich Co. NAD Class I 1988-04-13
K881385 PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANEL Psoralite Corp. FTC Class II 1988-04-13
K880153 POLYDERM A+B(TM) Laivan Corp. NAD Class I 1988-04-13
K880171 MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL Cooper Lasersonics, Inc. LNK Class II 1988-04-11
K881176 STERILE ESMARCH BANDAGE Spectrum/Hydro-Med Products, Inc. GAX Class I 1988-04-11
K881394 NON-STERILE SUTURE NEEDLES China National Medicines C/O Havel'S GDL Class I 1988-04-08
K881144 YESNG PATIENT PLATE #80226 Ferguson Medical JOS Class II 1988-04-08
K881372 ENDICOTT & BEAMAN SUPRA-TEC FACE MASK Endicott & Beaman, Inc. FXX Class II 1988-04-08
K881083 GENERAL PURPOSE KIT Med-Dex Intl. LRO Class II 1988-04-07
K881292 ALLEN LATERAL ARMBOARD Edgewater Medical Systems, Inc. BTX Class I 1988-04-07
K881095 KOI(TM) INSTRUMENT TRAYS CooperVision, Inc. LRP Class I 1988-04-06
K881101 K ORTHOPEDIC TABLE Instrumentation Specialties, Inc. JEB Class I 1988-04-06
K881151 MICROSCRAPE Ortho Pharmaceutical Corp. LXK Class I 1988-04-06
K881353 MTI WOLFF SYSTEM Health Systems Intl., Inc. LEJ Class II 1988-04-06
K881157 STERNUM SPREADER AND MITRAL VALVE RETRACTOR T. Korossurgical Instruments Corp. GAD Class I 1988-04-06
K881156 UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR T. Korossurgical Instruments Corp. GAD Class I 1988-04-05
K881159 I.M.A. RETRACTOR T. Korossurgical Instruments Corp. GAD Class I 1988-04-05
K880535 PROFECT SURGEONS' GLOVES Network Trading Corp. KGO Class I 1988-04-05
K881069 DISPOSABLE STERILE LATEX SURGICAL GLOVES Komin Trading Co. KGO Class I 1988-04-05
K880377 NOVO VIVO MODEL #17140 AND #17135 Genesis Industries, Inc. GAA Class I 1988-04-04
K881050 DUODERM(R) CGF Convatec, A Division of E.R. Squibb & Sons NAD Class I 1988-04-01
K881191 REGAL LATEX SURGICAL GLOVES Maxcare, Inc. KGO Class I 1988-04-01
K880632 PROTEQ SURGEON'S GLOVES Strategic Materials Group KGO Class I 1988-03-31
K874894 TECNOL LASER SURGICAL MASK Tecnol New Jersey Wound Care, Inc. FXX Class II 1988-03-28
K871934 MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE Lasermatic, Inc. LNK Class II 1988-03-25

16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.