meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
36
Latest Decision
1993-02-10

Clearances · page 114 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K924128 CHOLANGIOGRAPHY CATHETER Applied Medical Resources GBZ Class I 1993-02-10
K922116 POWDER FREE NITRILE GLOVE Hpi, Inc. KGO Class I 1993-02-08
K920118 RESORABPLUG Sofamor Danek Mfg., Inc. LZN Class II 1993-02-08
K924725 AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS American Biomaterials Corp. MDM Class I 1993-02-05
K924503 PERSONNA SAFETY SCALPEL American Safety Razor Co. MDM Class I 1993-02-05
K924114 HISTOFREEZER Solarcare Technologies Corp,Inc. GEH Class II 1993-02-05
K926306 FOOT CONTROL PENCIL Megadyne Medical Products, Inc. GEI Class II 1993-02-05
K924166 OPTILINK(TM) LPM (LASER POWER MODULATOR) Xintec Corporation GEX Class II 1993-02-05
K925033 STILLE AUTOMATIC TOURNIQUET Ferguson Medical KCY Class I 1993-02-01
K925749 KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML Kendall Healthcare Products Co. Div.Of Tyco Health GCY Class I 1993-02-01
K924984 SPECIALIST(R) WALKER Johnson & Johnson Orthopaedics, Inc. FYH Class I 1993-02-01
K923799 SMOKE EATER Nordex Medical Corp. FYD Class II 1993-01-29
K923188 DYNASTY IMPERVIOUS ISOLATION J-SUIT Dynatech Medical Products FYC Class II 1993-01-29
K914702 STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS Depuy, Inc. FXP Class I 1993-01-29
K925108 INTEGRATED VISUALIZATION SYSTEM Neuro Navigational Corp. FWF Class I 1993-01-29
K924918 FORCE GSU HANDSET W/LAPAROSCOPIC ELECTRODE (28CM) Valleylab, Inc. GEI Class II 1993-01-29
K922802 MICROSURGE FRONT-END GRASPING DEVICES Microsurge, Inc. GEI Class II 1993-01-29
K923576 STERILE NATURAL RUBBER LATEX SURGIONS' GLOVES Mri Corp. KGO Class I 1993-01-29
K923187 IMPERVIOUS ISOLATION SHOE COVERS Dynatech Medical Products FXW Class I 1993-01-29
K920162 TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK Tecnol Medical Products, Inc. FXX Class II 1993-01-27
K923798 SURGICAL GOWN PACK Central Georgia Ancillary Health Systems KKX Class II 1993-01-27
K923688 N-PAC National Healthcare Linen Service KKX Class II 1993-01-27
K915591 STERILE GAUZE PADS Eagle Medical, Inc. NAB Class I 1993-01-27
K915817 TECNOL FLUIDSHIELD INFECTION CONTROL MASK Tecnol Medical Products, Inc. FXX Class II 1993-01-27
K914520 DIOMED 25 SURGICAL DIODE LASER, UROLOGY APPLICAT Dio-Med Corp. GEX Class II 1993-01-22
K923302 TENDERLETT FINGER International Technidyne Corp. FMK Class II 1993-01-22
K923928 BIPOLAR COAGULATOR/IRRIAGATION SYSTEM Valley Forge Scientific Corp. GEI Class II 1993-01-22
K922145 SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS Atos Medical AB KAM Class I 1993-01-21
K922126 HOSPITAL KIT ENT 1125 Savoy Medical Supply Co., Inc. LRP Class I 1993-01-21
K924953 FLUID COOLED BONE SAW BLADE, 6000 SERIES Boehringer Laboratories GFA Class I 1993-01-21
K920745 NUTEX GLOVES Ansell Intl. KGO Class I 1993-01-21
K914883 CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG Circon Video GEI Class II 1993-01-15
K914521 DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT Dio-Med Corp. GEX Class II 1993-01-15
K924729 EXCEL TRIPULSE MODEL3000 Excel Tech. , Ltd. GEX Class II 1993-01-15
K922289 SESQUIPOLAR(TM) MIS ELECTRODE Beacon Laboratories, Inc. GEI Class II 1993-01-15
K924158 CANDELA LASSER SYSTEMS MODIFIED Candela Laser Corp. GEX Class II 1993-01-15
K924700 FISK HEADREST Rhino Mfg. FQO Class I 1993-01-15
K925748 KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN Kendall Healthcare Products Co. Div.Of Tyco Health GBX Class I 1993-01-13
K924702 TURKEL ABDOMINAL PARACENTESIS SYSTEM Symbiosis Corp. GBX Class I 1993-01-12
K922308 TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER Ti-Mesh, Inc. FTM Class II 1993-01-12
K922409 ALM ILLUMINATOR SERIES LIGHT SYSTEM Alm Surgical Equipment, Inc. FSQ Class II 1993-01-12
K922062 THE DENVER CAUTERY Denver Splint Co. GEI Class II 1993-01-12
K924273 ACCUFLATE Instrumed, Inc. KCY Class I 1993-01-12
K925533 ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET Angeion Corp. GBX Class I 1993-01-12
K924650 GAUZE SPONGES Dav-Mar Medical Products, Inc. NAB Class I 1993-01-11
K922555 ENVIROMATE(TM) SMOKE EVACUATION SYSTEM Lase, Inc. FYD Class II 1993-01-06
K923283 SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT Savoy Medical Supply Co., Inc. KKX Class II 1993-01-04
K923161 BRAIDED POLYESTER SUTURE MATERIAL Mitek Surgical Products, Inc. GAS Class II 1992-12-30
K925903 LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION Birtcher Medical Systems, Inc. GEI Class II 1992-12-30
K925171 FREE SUN PRO DESIGN 3000 AND 3800 Free Sun Prod. AB FTC Class II 1992-12-29
K925619 DISPOSABLE HAND-SWITCHING ESU PENCIL Beacon Laboratories, Inc. GEI Class II 1992-12-24
K923855 SHARPULSE Sharplan Lasers, Inc. GEX Class II 1992-12-24
K923657 SUPPLE PERI-GUARD Bio-Vascular, Inc. FTM Class II 1992-12-21
K923812 CENTURION DISPOSABLE INSTRUMENTS Tri-State Hospital Supply Corp. MDM Class I 1992-12-17
K923872 BONE MARROW BIOPSY SYSTEM The Straumann Co. GDM Class I 1992-12-15
K915218 ULTRALON POWDERFREE SURGICAL GLOVES Johnson & Johnson Medical, Inc. KGO Class I 1992-12-15
K922807 FIBERLIFE Laser Surgical Systems GEX Class II 1992-12-15
K922339 SUTURE REMOVAL KIT Transidyne General Corp. MCZ Class I 1992-12-11
K920876 CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER Medtech Intl., Inc. KGO Class I 1992-12-11
K923160 3DSCOPE American Surgical Technologies Corp. FWF Class I 1992-12-10
K924188 BI-TECH I BIPOLAR COAGULATOR/CUTTING SYSTEM Valley Forge Scientific Corp. GEI Class II 1992-12-10
K915827 A.C.S. SUTURE REMOVAL KIT American Carolina Stamping MCZ Class I 1992-12-08
K923602 ABSORBENT PAD -- MODIFICATION Winfield Laboratories, Inc. NAB Class I 1992-12-07
K921022 DISPOSABLE CURETTE Dermtec, Inc. MDM Class I 1992-12-03
K922999 SEGAL REUSABLE ELECTRODE Bernsco Surgical Supply, Inc. GEI Class II 1992-11-27
K921297 DRAGER DVE 4000 SERIES SYSTEM Alm Surgical Equipment, Inc. FQO Class I 1992-11-27
K923563 SYMBIOSIS SUCTION-IRRIGATOR Symbiosis Corp. GEI Class II 1992-11-25
K923896 HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS Heraeus Lasersonics, Inc. GEX Class II 1992-11-25
K922515 PROFEEL ANATOM SURG GLOVES (POWDER FREE/HYPOALLER) Wembley Rubber Products (M) Sdn Bhd KGO Class I 1992-11-25
K923845 DEXIDE LAPAROSCOPIC ACCESSORIES Dexide, Inc. GEI Class II 1992-11-25
K922666 TRANSORB(TM) ULCER & WOUND DRESSING Brady Medical Products Co. NAE Class I 1992-11-23
K924749 TRELEX MESH Meadox Medicals, Div. Boston Scientific Corp. FTL Class II 1992-11-23
K923115 CLINISORB Hermitage Hospital Products, Inc. NAB Class I 1992-11-23
K923416 O.R. CONCEPTS' ELECTROSURGICAL PROBE O.R. Concepts, Inc. GEI Class II 1992-11-20
K922901 INCISOR I PULSED ND:YAG LASER SYSTEM Buckman Co., Inc. GEX Class II 1992-11-20
K923199 O.R. CONCEPTS ELECTROSURGICAL PROBES O.R. Concepts, Inc. GEI Class II 1992-11-20
K924077 HANDISOL National Biological Corp. FTC Class II 1992-11-20
K921988 LACERATION REPAIR TRAY Cypress Medical Products, Ltd. MDM Class I 1992-11-19
K922176 INTELIJET SUCTION SUPPLY Smith & Nephew Dyonics, Inc. BTA Class II 1992-11-18
K921696 CUTTING AND COAGULATION DEVICES AND ACCESSORIES American Cyanamid Co. GEI Class II 1992-11-18
K922423 ACCESS SURGICAL BIPOLAR ENDOSCOPIC SURG. INSTRUM. Access Surgical Intl., Inc. GEI Class II 1992-11-18
K923953 MEGABEAM Ceram Optec, Inc. GEX Class II 1992-11-17
K922425 ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM Access Surgical Intl., Inc. GEI Class II 1992-11-17
K922881 CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC Clarus Medical Systems, Inc. GEX Class II 1992-11-16
K922507 GERSON ISOLAIR APR PARTICULATE SURGICAL MASK Louis M. Gerson Co., Inc. FXX Class II 1992-11-16
K924214 ECLIPSE 2100(TM) MODEL 32 Cardiogenes GEX Class II 1992-11-16
K914334 ALCON(R) FX2(TM) PHOTOCOAGULATOR Alcon Laboratories GEX Class II 1992-11-13
K923647 RFG-DGP DISPOSABLE GROUNDING PADS Radionics, Inc. JOT Class II 1992-11-09
K920166 MODULAR DESIGN ELECTROSURGICAL LAPAROSCOPY INTR Conmedcorp GEI Class II 1992-11-06
K920708 MULTILASE 2500 A Teknomed, Inc. GEX Class II 1992-11-05
K913917 MULTILASE 2100 C, 2100 D Teknomed, Inc. GEX Class II 1992-11-05
K915731 ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL Elmed, Inc. GEI Class II 1992-11-05
K923909 CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL Orthomet, Inc. LZN Class II 1992-11-04
K922837 S1500 XENON LIGHT SOURCE Endomedix HBI Class II 1992-11-03
K923616 OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR Osteonics Corp. JDK Class II 1992-10-30
K923539 AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP American Dental Laser, Inc. GEX Class II 1992-10-28
K915807 EUDERMIC POWDER-FREE SURGICAL GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic KGO Class I 1992-10-28
K921804 DEXTRON SURGICAL GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic KGO Class I 1992-10-28
K921990 ASI UROPLASTY LASER CYSTOSCOPE Advanced Surgical Intervention, Inc. GEX Class II 1992-10-28
K923341 ZEISS VISULAS ARGON LASER Carl Zeiss, Inc. GEX Class II 1992-10-28

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