meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
54
Latest Decision
1987-12-30

Clearances · page 135 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K874928 WHOLEY (TM) BIOPSY DEVICE Medrad, Inc. GDM Class I 1987-12-30
K874961 BONE CUTTING INSTRUMENTS & ACCESSORIES Solway, Inc. GDR Class I 1987-12-30
K874888 ISOLATION GOWN Sage Products, Inc. FYC Class II 1987-12-30
K874889 U.V. SUNLAMP 95 UF-11 Light Sources, Inc. FTC Class II 1987-12-30
K874653 STERILE SURGICAL SCRUB BRUSH Surgikos, Inc. GEC Class I 1987-12-30
K872528 OMNIFIT DISTAL STEM CEMENT SPACERS Osteonics Corp. JDK Class II 1987-12-29
K874241 OPMI MD SURGICAL MICROSCOPE Carl Zeiss, Inc. FSO Class I 1987-12-23
K874553 ENVISAN PASTE Marion Laboratories, Inc. KOZ Class I 1987-12-18
K874470 MWI 400 WOUND DRESSING Med-West, Inc. NAD Class I 1987-12-18
K874879 AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE United States Surgical, A Division of Tyco Healthc GDH Class I 1987-12-17
K874086 3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX 3M Company KKX Class II 1987-12-17
K873654 MONOPOLAR CAUTERY CONICAL TIP #TM-1702 Arthropedics, Inc. JOS Class II 1987-12-15
K873655 MONOPOLAR CAUTERY RETROGADE TIP #TM-1703 Arthropedics, Inc. JOS Class II 1987-12-15
K873653 MONOPOLAR CAUTERY BLADE TIP #TM-1701 Arthropedics, Inc. JOS Class II 1987-12-15
K874099 REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE Biopro, Inc. KGO Class I 1987-12-14
K874794 E600B FOOTSWITCH Valleylab, Inc. BWA Class II 1987-12-14
K874539 HI-TOUCH (TM) BRAND SURGICAL GLOVES Apex Medical Technologies, Inc. KGO Class I 1987-12-14
K874766 INTERPRO INT'L, INC. ISOLATION GOWN Interpro Intl., Inc. FYC Class II 1987-12-10
K874760 CK 4900 SERIES, GOWN AND TOWEL PAK Currie Medical Specialties, Inc. LRO Class II 1987-12-10
K874741 STERI-CLENS(TM) SURGICAL SCRUB SPONGE Absorbent Cotton Co., Inc. GEC Class I 1987-12-10
K874762 ARTHROTRACT UPPER LIMB TRACTION ACCESSORY Andronic Devices, Ltd. JEA Class I 1987-12-10
K874063 ENTERON ABDOMINAL PARACENTESIS TRAY Endovations KDD Class I 1987-12-04
K874161 MODIFIED USE OF TRIANGLE BANDAGE STERILE K. W. Griffen Co. NAD Class I 1987-12-04
K874645 CLOSED WOUND DRAINAGE SYSTEMS Hall Laboratories, Inc. GCY Class I 1987-12-02
K874585 ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE Angiomed U.S., Inc. DWO Class I 1987-12-02
K874596 PERFORATED SOAKING TUBE Specialty Medical Products Co. GBQ Class I 1987-12-02
K874503 MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER Micro-Aire Surgical Instruments, Inc. HWM Class I 1987-12-02
K874608 TECNOL FLUID SHIELD SURGICAL MASK Tecnol New Jersey Wound Care, Inc. FXX Class II 1987-12-02
K874318 MAXIMUM CONTROL GOWN Ulti-Med Intl., Inc. FYC Class II 1987-12-02
K874428 AUTO SUTURE PURSE STRING APPLIER* United States Surgical, A Division of Tyco Healthc GDJ Class I 1987-12-02
K874634 NSN #6515-00-333-2400 ADSON DRESSING FORCEPS I-Tech Industries, Inc. GEN Class I 1987-12-02
K874276 CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER Cox-Uphuff Intl. FZW Class I 1987-12-02
K873309 REFLEX(TM) CA-T CLIP APPLIER Richard-Allan Medical Ind., Inc. FZP Class II 1987-11-27
K873760 SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER Coherent Medical Group GEX Class II 1987-11-27
K873079 ARTHROBOT 100 UPPER LIMB POSITIONER Andronic Devices, Ltd. JEA Class I 1987-11-25
K873387 VIDEO ARTHROSCOPE, 1.7MM X 55 MM Arthropedics, Inc. HXR Class I 1987-11-25
K873080 ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY Andronic Devices, Ltd. JEA Class I 1987-11-25
K873940 CREAT BRAND O-RISE GENERAL ASPIRATOR Aesthetech Corp. BTA Class II 1987-11-25
K874352 TUMORIMETER Cancer Technologies, Inc. FTY Class I 1987-11-23
K874053 INFLATABLE FULL ARM SPLINT Vinyl Technology, Inc. FZF Class I 1987-11-23
K874051 INFLATABLE FULL LEG SPLINT Vinyl Technology, Inc. FZF Class I 1987-11-23
K873978 DISPOSABLE BIPOLAR FORCEPS E.M. Adams GEN Class I 1987-11-23
K874052 INFLATABLE HALF LEG SPLINT Vinyl Technology, Inc. FZF Class I 1987-11-23
K874357 TAPERED PUNCH Med-Tool, Inc. LRY Class I 1987-11-23
K874494 KAMBIN LAMINECTOMY FRAME Avec Scientific Design Corp. LWG Class I 1987-11-23
K874356 PIN PUNCH Med-Tool, Inc. LRY Class I 1987-11-23
K874050 INFLATABLE FOOT & ANKLE SPLINT Vinyl Technology, Inc. FZF Class I 1987-11-23
K873809 EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001 Zimmer Aspen Labs BWA Class II 1987-11-20
K873973 LAKE WOUND CARE/TREATMENT KIT Lake Medical Products, Inc. LRO Class II 1987-11-20
K874439 SOFT TISSUE ANCHORING SET KIT Concept, Inc. LRO Class II 1987-11-20
K873330 KTP/532 LASER Laserscope LNK Class II 1987-11-18
K872448 BLOOD CONTAINMENT PACK Professional Medical Services LRO Class II 1987-11-17
K873645 STAINLESS 22-13-5 SUTURE WIRE Zimmer, Inc. GAQ Class II 1987-11-17
K874342 LIGATURE CARRIER/PACKER, HYDROXYLAPATITE Cox-Uphuff Intl. GEJ Class I 1987-11-13
K874243 ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000 Pilling Co. GAD Class I 1987-11-13
K874370 SURGICAL PREP RAZOR Derma-Safe Co. LWK Class I 1987-11-13
K874291 EPI-LOCK T.M. PRIMADERM Derma-Lock Medical Corp. NAD Class I 1987-11-10
K873246 MODEL 5001 MICROMANIPULATOR FOR USE W/TF-25 CO2 Coherent Medical Group GEX Class II 1987-11-10
K872935 ANTI-INFECTION SHIELD Stackhouse Assoc. FXX Class II 1987-11-09
K873664 LIGHT-SPOT FIBEROPTIC LASER HANDPIECE Laserguide GEX Class II 1987-11-06
K874023 LEVTECH CLAMP APPLIER Levtech, Inc. HTD Class I 1987-11-06
K873571 LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE Laserguide GEX Class II 1987-11-06
K874066 SURGICAL CAPS Interpro Intl., Inc. FYF Class I 1987-11-04
K874064 SHOE COVERS Interpro Intl., Inc. FXP Class I 1987-11-04
K873512 SERRATED GRASPING FORCEPS, RIGHT Arthropedics, Inc. HTD Class I 1987-11-02
K872281 RAYLOR FUSION FUNNEL Cedar Surgical, Inc. HXR Class I 1987-11-02
K873513 SERRATED GRASPING FORCEPS, CURVED UP Arthropedics, Inc. HTD Class I 1987-11-02
K873506 CUP BIOPSY FORCEPS, CURVED UP Arthropedics, Inc. HTD Class I 1987-11-02
K873503 CUP BIOPSY FORCEPS, LEFT Arthropedics, Inc. HTD Class I 1987-11-02
K873504 CUP BIOPSY FORCEPS, RIGHT Arthropedics, Inc. HTD Class I 1987-11-02
K873419 VIDEO PRINTER SYSTEM Technology For Imaging, Inc. KQM Class I 1987-11-02
K873505 CUP BIOPSY FORCEPS, CURVED DOWN Arthropedics, Inc. HTD Class I 1987-11-02
K873510 SERRATED GRASPING FORCEPS, CURVED DOWN Arthropedics, Inc. HTD Class I 1987-11-02
K874234 SURGICAL PREP RAZOR, STRAIGHT TYPE Derma-Safe Co. LWK Class I 1987-11-02
K873511 SERRATED GRASPING FORCEPS, LEFT Arthropedics, Inc. HTD Class I 1987-11-02
K873785 TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPE Tecnol New Jersey Wound Care, Inc. FXX Class II 1987-11-02
K873469 TODD MEDICAL/SKILLED CARE PRODUCTS Todd Medical, Inc. LRP Class I 1987-10-29
K873589 PERFECT SUNTANNING BED Wolff System Technology Corp. LEJ Class II 1987-10-29
K874279 AHH NATURAL BREAST FORM Pacific Prosthetics, Inc. GBI Class I 1987-10-29
K873377 CLOSED CHEST DRAINAGE SET W/SUTURES Gish Biomedical, Inc. GBS Class I 1987-10-28
K873595 SURGICAL PENCIL/ ELECTROSURGICAL PENCIL Yuntek International, Inc. GEI Class II 1987-10-26
K873690 CEDAR(TM) PELVIC CUSHION Cedar Surgical, Inc. LWG Class I 1987-10-26
K873141 LASER RESISTANT DRAPE Baxter Healthcare Corp KKX Class II 1987-10-23
K873928 UNIVERSAL TOURNIQUET Dryden Corp. GAX Class I 1987-10-23
K873830 TECNOL SURGEON'S CAP Tecnol New Jersey Wound Care, Inc. FYF Class I 1987-10-23
K873786 SMITH & NEPHEW DAYLIGHTER(TM) Smith & Nephew, Inc. FSY Class II 1987-10-23
K873471 LMI CHOLANGIOGRAM TRAY Lazarus Medical Innovations, Inc. GBZ Class I 1987-10-23
K873848 RETROBULBAR NEEDLE Healthtek, Inc. GDM Class I 1987-10-23
K873963 COHERENT XA-30 CO2 SURGICAL LASER Coherent Medical Group GEX Class II 1987-10-19
K874044 INTRA-ARTICULAR ARTHROSCOPIC SHAVER Medline Industries, Inc. HWE Class I 1987-10-15
K872094 VACU-AIDE The Devilbiss Co. JCX Class II 1987-10-15
K872870 LASER OPTICAL FIBERS - DISPOSABLE Optimed Therapeutics LNK Class II 1987-10-14
K873773 ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER Hgm, Inc. GEX Class II 1987-10-13
K872179 CODMAN NEUROLASE LASER SYSTEM Codman & Shurtleff, Inc. GEX Class II 1987-10-07
K873705 CARERITE FACE MASK Cost Rite Health Products, Inc. FXX Class II 1987-10-05
K872578 MDS-90 ARGON DYE LASER FOR DERMATOLOGY Meditec of America GEX Class II 1987-10-01
K873742 HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES Hood Laboratories NWA Class II 1987-10-01
K873744 LEUKOCLIP(R) Beiersdorf, Inc. FZQ Class I 1987-09-30
K873591 A.R.M. (ASPEN RETURN MONITOR) Qmed, Inc. GEI Class II 1987-09-30
K872711 MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY Directed Energy, Inc. GEX Class II 1987-09-28

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