FDA 510(k) clearances — page 997
clearances on record, most recent first.
Clearances — page 997
99,601–99,700 of 176,637- K961098 — BIO-DRESSING, STERILE ISLAND DRESSING
- K934695 — NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA
- K953452 — KETOREX C SANWA
- K954828 — ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
- K955684 — RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY
- K955707 — ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT
- K960180 — 22 MM COCR HEAD & POLYETHLENE LINER
- K960377 — ENA-C-T TOTAL CHOLESTEROL TEST
- K960427 — ABBOTT CELL-DYN 3500R SYSTEM
- K960429 — PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
- K960806 — TURBO TRACKER
- K961293 — QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2
- K955382 — 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
- K960080 — ACCUTEMP PROBE
- K960519 — MARTECH ENDOSCOPIC INJECTION NEEDLE
- K960733 — MINISTICK PREGNANCY TEST
- K960757 — KARL STORZ URETER RESECTOSCOPE
- K961372 — SERUM TOX CALIBRATOR
- K950646 — INTEGRATOR
- K952631 — BRAUN HEMODIALYSIS BLOOD CIRCUITS
- K953300 — V-CATH DUAL LUMEN E.S.P. PERIPHERAL INSERTED CENTRAL CATHETER
- K954158 — STC DIAGNOSTICS AUTO-LYTE PH ASSAY
- K954171 — ARCO-MBC, ARCO MC
- K954506 — EMOX
- K954570 — ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
- K955247 — OLYMPUS KD SERIES SPHINCTEROTOME
- K955397 — MAYFIELD-ACCISS WORKSTATION
- K960001 — MINIMED INFUSION PUMP, MODEL MMT-507
- K960581 — SECURE EVA DUAL CHAMBER MIXING BAG
- K960613 — GE ADVANTAGE WINDOWS REVIEW WORKSTATION
- K960694 — ZOMED 30F ELECTROSURGICAL PROBE
- K960695 — MODEL 200C ELECTROSURGICAL PROBE
- K960825 — LM ANCHOR OR OTHER PROPRIETARY NAME
- K961074 — LIGHTSOURCE OR ILLUMINATOR
- K961135 — INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)
- K961185 — DAUM BIOPSYNEEDLE
- K961441 — TONOMETERED SLAINE BLOOD GAS CONTROL
- K943145 — AMERICAN, ECONOMY CLASSIC SUNGLASSES AND LOGO LENS CONTRA VISION SUNGLASSE
- K951549 — EBNA IGG EIA TEST SYSTEM
- K954552 — RAILWIRE
- K954622 — IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK
- K954903 — PEDI VAGINAL ASPIRATOR
- K955093 — ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511
- K960040 — SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE
- K960316 — CLEARBLUE EASY
- K960381 — MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION
- K960563 — SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES
- K960657 — SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE
- K960815 — DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL
- K960880 — MILL-ROSE BLIND MICROBIOLOGY BRUSH
- K960923 — CARBOMEDICS MITRAL ROTATOR
- K961131 — SALICYLATE ASSAY
- K942844 — LEVEL 1 BLOOD STREAM RECOVERY SYSTEM
- K953443 — CONSENSUS PCL SUBSITUTING TIBIAL INSERT
- K955341 — NIL LATEX POWDERFREE EXAMINATION GLOVES
- K955355 — VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
- K955888 — PREPOWDERED LATEX EXAMINATION GLOVES
- K955889 — POWDERFREE LATEX EXAMINATION GLOVES
- K960103 — DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS
- K960279 — NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES
- K960372 — SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM
- K960395 — PLANCON MIRCOLAMELLAR KERATOME
- K960397 — MEDICATOR AEROSOL DRUG DELIVERY SYSTEM
- K960407 — COMFIT ORTHOPEDIC
- K960415 — WILSON-COOK BALLOON INFLATION DEVICE
- K960416 — COMFIT MICROPTIC
- K960468 — DMR/CO2 COMBO KTI
- K960475 — MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM
- K960488 — NEO 2 LINE SUCTION SYSTEM
- K960521 — SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER
- K960548 — AH PLUS ROOT CANAL SEALER
- K960561 — DSL ACTIVE PROLACTIN ELISA MODEL 10-4500
- K960562 — GLEESON FLO VAC & SELECTONE S/I CANNULAE MODEL 60-6001, 6002, 6005
- K960572 — THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER
- K960585 — WOUND CARE COMPRESSION SYSTEM (WCCS)
- K960594 — LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS
- K960595 — FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS
- K960596 — ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE
- K960597 — ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE
- K960598 — CONCORD MARYLAND BRIDGE CEMENT
- K960599 — SUPERIOR PHOTOCURING HYBRID COMPOSITE
- K960600 — LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS
- K960729 — ENAMEL CONDITIONER (ENAMEL ETCHING AGENT)
- K960823 — PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
- K960873 — MODEL 1210, MEDIUM E-NET
- K960885 — MODEL 1240, SMALL E NET
- K961076 — MM 324
- K961148 — CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)
- K961161 — AVL OPTI 1 PH/BLOOD GAS ANALYZER
- K961192 — IRRIGATION SYSTEM
- K954401 — GASTROTEC
- K954486 — MERCURY AIRWAY PRESSURE MANOMETER
- K954800 — APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)
- K954976 — POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)
- K955013 — NOVA CO-OXIMETER ANALYZER
- K955464 — TACTYLON POWDER FREE EXAMINATION GLOVE
- K955556 — FLUID RESISTANT MASK
- K955557 — FLUID REISISTANT EYESHIELD MASK
- K960275 — OPUS CK-MB & TOTAL CK CONTROLS
- K960379 — ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE
Data sourced from openFDA. This site is unofficial and independent of the FDA.