FDA 510(k) clearances — page 1051
clearances on record, most recent first.
Clearances — page 1051
105,001–105,100 of 176,637- K950404 — LOCKETT MEDICAL CORP. GAUZE
- K951012 — N/T PROTEIN CONTROL PY
- K951013 — OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT
- K951049 — SPECULUM, ENT (S3)
- K951050 — SPECULUM, ENT (S3)
- K951055 — OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT
- K951186 — VARELISA ANA-4 SCREEN
- K951205 — VARELISA ANA PROFILE
- K951206 — VARELISA PARIETAL CELL ANTIBODIES
- K951207 — VARELISA HISTONE ANTIBODIES
- K951263 — INTRAARC DRIVE SYSTEM
- K951560 — RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS)
- K930013 — CO2 INSUFFLATOR 1100
- K931615 — NITE-GUIDE
- K934795 — CARD GUARD
- K935704 — DRIED GRAM-NEGATIVE MIC//COMBO PANELS
- K940009 — GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300
- K941616 — VARIANT TOTAL GHB PROGRAM
- K941709 — ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS
- K943681 — STERI-OSS SCALER FOR DENTAL IMPLANTS
- K943883 — SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
- K945426 — ARTHREX CANCELLOUS SCREW AND WASHER
- K945454 — LEUR TIP CAP, VLT CAP(TM)
- K945629 — MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS
- K945639 — SPETZLER PIN
- K950159 — SURESHARP
- K950167 — PREMIER EHEC
- K950257 — MULTIPLE (IZON DBS & URINE COLLECTION KIT)
- K950266 — SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE
- K950308 — STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA
- K950316 — CORDIS STEERABLE GUIDEWIRES
- K950328 — AMOXICILLIN/CLAVULANIC ACID 2/1
- K950397 — SYSTEM 22 VALVE
- K950462 — GAUZE, NONABSORABLE, NON-MEDICATED (INTERNAL SPONGE)
- K950777 — OXYGEN REGULATOR
- K951000 — ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM
- K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING
- K951367 — PORTA-SCREEN SPIROMETER
- K951374 — RESOUND PERSONAL HEARING SYSTEM BT2/S-E
- K951375 — RESOUND PERSONAL HEARING SYSTEM ED3/S-E
- K951376 — RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTROL OPTION
- K951377 — RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION
- K951418 — LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILE
- K935466 — CLINICAL VOICE THERMOMETER
- K936266 — COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)
- K942359 — BONE PLATE SYSTEM
- K942374 — ALLURE (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
- K942799 — DATUM
- K943240 — FLEXIFLO SIX ENTERAL NUTRITION PUMP SET
- K944188 — SPINAL MARKER
- K945398 — BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE
- K945610 — ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP
- K946340 — BELTONE COMPARAFIT
- K950126 — ENDOSCOPIC LIGATION DEVICE, LIGATOR HANDLE, LIGATOR CARTRIDGE
- K950133 — HYPODERMIC SYRINGE PISTON
- K950137 — URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE
- K950164 — PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
- K950185 — TACTYLON(TM) POWDER FREE SURGEONS GLOVE
- K950211 — ELSA-PTH
- K950212 — A2 DETACHED DUAL PORT SYSTEM
- K950281 — MESH MATRIX WOUND DRESSING
- K950406 — DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES
- K950540 — IMPLANTABLE CLIP
- K950659 — ULTRACELL RETRACTOR COVERS
- K950677 — ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN
- K950998 — MODUILAR UNIPOLAR
- K951034 — AURA LASER SYSTEM
- K951135 — MULTI-DRUG CONTROL SET
- K951137 — COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC)
- K951171 — SCIPOTEX
- K951255 — IMEDGE VIDEO OSTOSCOPE (ANALOG)
- K940081 — MERCURY
- K940323 — ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM
- K943537 — MODEL 3470 X-TREL RF RECEIVER
- K945130 — BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER
- K945292 — TS-700P CONTROL XP ELECTRICAL STIMULATOR
- K945828 — ECHO PLANAR IMAGING I
- K950069 — DASHER-14
- K950343 — HYPERPACS PACS AND TELERAFIOLOGY SYSTEM
- K950983 — IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE
- K924523 — HYS-SURGIFLATOR
- K940112 — X-RAY FILM PROCESSOR
- K941435 — BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD
- K943448 — LUMIN
- K943965 — VIVAPORE 10
- K943966 — VIVAPORE 2
- K944759 — 200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM
- K945199 — RH2000 REAL EAR MEASUREMENT SYSTEM
- K946245 — TIELLE* HYDROPOLYMER DRESSING
- K946358 — ENDOSCOPIC BILIARY CATHETER
- K950469 — DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET
- K950570 — STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
- K950971 — MOBIL C-ARM, REGURBISHED, VARIOUS MODELS
- K951437 — OTI MODEL TLS-60
- K933177 — SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS
- K940772 — ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER)
- K943038 — STATLOCK-IPIDURAL
- K943186 — CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
- K943259 — 1085 ULTIMATE E PLETHYSMOGRAPH
- K943661 — STERILE PHYSIOLOGICAL SALINE/STERILE WATER
Data sourced from openFDA. This site is unofficial and independent of the FDA.