FDA 510(k) clearances — page 797
clearances on record, most recent first.
Clearances — page 797
79,601–79,700 of 176,637- K012286 — MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
- K003281 — LACTOSORB RAPIDFLAP
- K011423 — INPULSE DENTAL LASER
- K011459 — WUJIN #3 FEMORAL BONE PLATE
- K011460 — WUJIN #3 TIBIAL BONE PLATE
- K011527 — PRAXSYS RELIA TSH TEST
- K011695 — COLLAGEN DENTAL MEMBRANE
- K011807 — SCS CLARIS SPINAL SCREWS, TYPES V,G,E
- K011822 — PIT AND FISSURE CHEMICAL CURING SEALANT
- K012134 — GC E-LIGHT
- K012215 — QUIK-CHECK HOME PREGNANCY TEST
- K012287 — MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
- K012313 — CT COLONOGRAPHY/NAVIGATOR2
- K002790 — ADD-ON CONDYLE
- K002832 — CONDUCTIVE GEL FOR ULTRASOUND
- K010534 — CROSS-CHECKS DUAL, MODEL CI 125
- K011416 — MUSCLE IMAGING SYSTEM (MIS)
- K011666 — CHILLIT
- K011706 — FLEXICAST PRIME
- K011751 — TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
- K012282 — STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
- K981693 — SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
- K984380 — DISPO ETCH
- K993124 — DISPODRILL
- K993182 — DISPOPROPHY
- K010295 — MICROSTIM 100I TENS DEVICE
- K010345 — KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
- K010530 — GEO STRUCTURE
- K011031 — VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
- K011102 — ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
- K011386 — EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE
- K011397 — PERSYST REVEAL
- K011443 — THREADED CEMENT RESTRICTOR (CR) TITANIUM
- K011447 — IN SPACE 3D
- K011687 — MP-3C POWER BASE CHAIR, MODEL MP3C
- K011705 — SUPREMCAST
- K011707 — TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
- K011748 — FIRST FILL R.C.S.
- K011753 — TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
- K011768 — THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202
- K011917 — ADVANCED HIP ASSESSMENT SOFTWARE
- K011971 — NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
- K012068 — WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
- K012123 — NIDOIL
- K012200 — 1.5T INFINITY TWINSPEED MR SYSTEM
- K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
- K012370 — SOLARA JR. MANUAL WHEELCHAIR
- K010413 — MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
- K011368 — DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
- K011382 — XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
- K011458 — SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
- K011535 — CADENCE PRECISION INJECTOR, MODEL 103-0304
- K011951 — EZ SYRINGE
- K012085 — SOMNO STAR & SERIES SLEEP SYSTEM
- DEN010002 — GIVEN DIAGNOSTIC IMAGING SYSTEM
- K003839 — CENTRAL VENOUS CATHETER
- K010300 — MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
- K010332 — WAKO IMMUNOASSAY CALIBRATOR SET
- K010454 — THE ALBERTA LENS SM2, SULFOCON B
- K010500 — AUTOMATED WORKCELL CONTROL SOFTWARE
- K010738 — CANNULATED PLUS SCREW SYSTEM
- K010908 — MEDICON TITANIUM YASARGIL ANEURYSM CLIPS
- K010910 — MEDICON YASARGIL CLIP APPLYING FORCEPS
- K011251 — SPARC SLING SYSTEM
- K011372 — AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K011495 — ARTHREX BIO-POST AND WASHER
- K011521 — ORTHO VLC; ORTHO VLC CAPSULE
- K011791 — POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR
- K011792 — NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
- K012056 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
- K012059 — 8100/8500 VITAL SIGNS MONITOR
- K012066 — PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
- K012069 — MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT
- K012087 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
- K012090 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
- K012128 — PROTECTIV ACUVANCE IV CATHETER SYSTEM
- K012135 — POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K012158 — MODIFICATION TO: LONG LENGTH GAMMA NAIL
- K012166 — NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)
- K012167 — MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR
- K012217 — M5T INSTANT FEVER THERMOMETER
- K012255 — MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
- K012281 — TRS-2000 POWER TILT/POWER RECLINE SYSTEM
- K012299 — MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM
- K001780 — COPAN VIRAL TRANSYSTEM
- K003285 — EXAC TRAC 2.0 (NOVALIS BODY MODULE)
- K003580 — UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
- K010107 — R STENT BILIARY ENDOPROSTHESIS
- K010522 — SUREVUE URINE HCG
- K010541 — PREVISION CHEM
- K011131 — METHADONE MICROPLATE EIA URINE APPLICATION
- K011354 — HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
- K011489 — SUMMIT DUOFIX HIP PROSTHESIS
- K011522 — RESORBABLE BONE PINS
- K011582 — QCU ANALYTICAL SOFTWARE PACKAGE
- K011658 — CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
- K011672 — ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
- K011673 — ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE
- K011685 — BISTITE II DC
- K011865 — ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION
Data sourced from openFDA. This site is unofficial and independent of the FDA.