Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
70129–70152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 2004
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...
K032067 · JAQ
Proxima Therapeutics, Inc.
Radiology · 222d
Cleared Feb 10, 2004
CURAD SILVER ACTIVE GEL BANDAGE
K032462 · FRO
Beiersdorf AG
General & Plastic Surgery · 183d
Cleared Feb 10, 2004
CURAD SILVER BANDAGE
K032463 · FRO
Beiersdorf AG
General & Plastic Surgery · 183d
Cleared Feb 10, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
K032706 · JWY
Dade Behring, Inc.
Microbiology · 161d
Cleared Feb 10, 2004
LABONE MICRO-PLATE COTININE EIA
K033601 · DLJ
Labone, Inc.
Toxicology · 88d
Cleared Feb 10, 2004
POLARCATH PERIPHERAL DILATATION SYSTEM
K033622 · DQY
Cryo Vascular Systems, Inc.
Cardiovascular · 84d
Cleared Feb 10, 2004
CAPIOX CARDIOTOMY RESERVOIR
K033800 · DTN
Terumo Cardiovascular Systems...
Cardiovascular · 67d
Cleared Feb 10, 2004
CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
K033840 · JOY
CellaVision AB
Hematology · 62d
Cleared Feb 10, 2004
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK
K033941 · HQF
Bausch & Lomb, Inc.
Ophthalmic · 53d
Cleared Feb 09, 2004
MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
K031741 · CCK
Alaris Medical Systems, Inc.
Anesthesiology · 250d
Cleared Feb 09, 2004
CSTAT, MODELS 09-0014-01 AND 09-0014-02
K032125 · DXC
Vascular Control Systems, Inc.
Radiology · 214d
Cleared Feb 09, 2004
ONE.CLICK NEEDLE
K033575 · FMI
B.Braun Medical, Inc.
General Hospital · 89d
Cleared Feb 09, 2004
MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
K033674 · LCP
Seradyn, Inc.
Chemistry · 77d
Cleared Feb 09, 2004
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
K033713 · DIO
Dade Behring, Inc.
Toxicology · 75d
Cleared Feb 09, 2004
APOGEE ELITE
K034030 · GEX
Cynosure, Inc.
General & Plastic Surgery · 42d
Cleared Feb 06, 2004
TEETH IN AN HOUR - ARK IMPLANT CONCEPT
K030685 · DZE
Nobel Biocare AB
Dental · 338d
Cleared Feb 06, 2004
BAWMED E-Z BAG RESUSCITATOR
K031434 · BTM
Bawmed UK
Anesthesiology · 276d
Cleared Feb 06, 2004
PROCEARA COPINGS AND PONTIC
K032562 · ELL
Nobel Biocare AB
Dental · 170d
Cleared Feb 06, 2004
CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS
K033213 · EFB
Codent Technical Industry Co., Ltd.
Dental · 126d
Cleared Feb 06, 2004
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
K033703 · DYH
Dentsply Intl.
Dental · 73d
Cleared Feb 06, 2004
VOLAR RADIUS PLATE WITH ANGULAR STABILITY
K033756 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 67d
Cleared Feb 06, 2004
RESPIRONICS CUSTOM I ORAL APPLIANCE
K033822 · LRK
Respironics, Inc.
Dental · 58d
Cleared Feb 06, 2004
RESPIRONICS CUSTOM II ORAL APPLIANCE
K033823 · LRK
Respironics, Inc.
Dental · 58d
Cleared Feb 06, 2004
HERMES BOND
K033974 · KLE
3M Espe AG Dental Products
Dental · 46d