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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
142129–142152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1986
IDEX DENTAL IMPLANT
K862177 · DZE
R. J. Chapman, D.M.D.
Dental · 176d
Cleared Dec 02, 1986
SENTINEL 4 EEG ANALYZER
K863193 · GWQ
Axon Systems, Inc.
Neurology · 105d
Cleared Dec 02, 1986
MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME
K863805 · JWH
Zimmer, Inc.
Orthopedic · 63d
Cleared Dec 02, 1986
TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY
K863935 · JAK
Toshiba Medical Systems
Radiology · 54d
Cleared Dec 02, 1986
EMPI MODEL 712, LOGIX(TM), NMS
K864010 · IPF
Empi
Physical Medicine · 48d
Cleared Dec 02, 1986
KNEECPM
K864427 · BXB
Invacare Corp.
Physical Medicine · 20d
Cleared Dec 02, 1986
FOUNDATIONS PLUS GIRDLE SUPPORT GARMENT 5000
K864477
Foundations Plus, Inc.
General & Plastic Surgery · 19d
Cleared Dec 01, 1986
HYDROPHILIC REPROSIL
K863288 · ELW
Dentsply Intl.
Dental · 98d
Cleared Dec 01, 1986
HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETER
K863750 · LJT
C.R. Bard, Inc.
General Hospital · 67d
Cleared Dec 01, 1986
VISCOPASTE ZINC PASTE BANDAGE
K863930 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 54d
Cleared Dec 01, 1986
CARBONET ODOUR ADSORBING DRESSING
K863931
Smith & Nephew, Inc.
General & Plastic Surgery · 54d
Cleared Dec 01, 1986
ELM ALLERGEN DISC
K863973 · DHB
Immuno Nuclear Corp.
Immunology · 48d
Cleared Dec 01, 1986
MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR
K864289 · KCW
Alexander Thomas, Inc.
General & Plastic Surgery · 31d
Cleared Dec 01, 1986
MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX
K864342 · CFN
Eiken Chemical Co., Inc.
Immunology · 27d
Cleared Dec 01, 1986
DISPOSABLE PHARMASEAL TEMPERATURE MONITORING PROBE
K864397 · FLL
American Pharmaseal Div. Ahsc
General Hospital · 25d
Cleared Dec 01, 1986
RAIL CLAMP EXTENSION PIECE
K864459 · FWZ
American Container Technology, Inc.
General & Plastic Surgery · 19d
Cleared Dec 01, 1986
3 RING ATTACHMENT
K864555 · FMF
Professional Medical Services
General Hospital · 12d
Cleared Dec 01, 1986
AQUALUBE(TM)
K864556 · KMJ
Parker Laboratories, Inc.
General Hospital · 12d
Cleared Nov 28, 1986
AVP TELEIMAGING SYSTEM
K862158 · LMD
Advanced Video Products, Inc.
Radiology · 175d
Cleared Nov 28, 1986
ELECTRONIC ULTRASOUND SCANNER, MODEL EUB-340
K862165 · IYO
Hitachi Medical Corp. of America
Radiology · 175d
Cleared Nov 28, 1986
EBV/VCA-CHECK(TM) ANTIGEN SLIDES
K863408 · GNP
Diagnostic Technology, Inc.
Microbiology · 86d
Cleared Nov 28, 1986
CREATIVE CARE SYSTEMS' IV START KIT
K863796 · LRS
American Biomaterials Corp.
General & Plastic Surgery · 60d
Cleared Nov 28, 1986
TOXOPLASMA IGG MICROASSAY
K863813 · LGD
Diamedix Corp.
Microbiology · 59d
Cleared Nov 28, 1986
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 49d