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
143113–143136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1986
SUTTER LESSER METATARSAL CAP
K861983 · KWD
Sutter Biomedical, Inc.
Orthopedic · 109d
Cleared Sep 08, 1986
ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM
K862189 · LGD
Organon Teknika Corp.
Microbiology · 91d
Cleared Sep 08, 1986
CIBA CORNING MAGIC LITE ANALYZER
K862235 · JJE
Ciba Corning Diagnostics Corp.
Chemistry · 89d
Cleared Sep 08, 1986
DAS 211
K862593
Philips Medical Systems (Cleveland),...
Radiology · 62d
Cleared Sep 08, 1986
TINA-QUANT(R) IGM
K862762 · DFT
Boehringer Mannheim Corp.
Immunology · 48d
Cleared Sep 08, 1986
HALL CANNLULA SYSTEM
K862778 · HRX
Hall Surgical, Division of Zimmer, Inc.
Orthopedic · 48d
Cleared Sep 08, 1986
125-I TSH RECEPTOR ANTIBODY KIT
K863006 · JZO
Cronus
Immunology · 31d
Cleared Sep 08, 1986
US PLUS-PAK(R) SURGICAL SYSTEM
K863209 · HQC
Ipax, Inc.
Ophthalmic · 19d
Cleared Sep 05, 1986
OMF-7101 FETAL MONITOR
K860237 · HGM
Nihon Kohden America, Inc.
Obstetrics & Gynecology · 225d
Cleared Sep 05, 1986
SYRINGE INFUSION PUMP
K860353 · FRN
Travenol Laboratories, S.A.
General Hospital · 218d
Cleared Sep 05, 1986
DUMBACH TITANIUM MESH IMPLANT SYSTEM
K862532 · JEY
Walter Lorenz Surgical, Inc.
Dental · 65d
Cleared Sep 05, 1986
PHOTO CLEARFIL BRIGHT
K862942 · EBF
Kuraray Co.
Dental · 31d
Cleared Sep 05, 1986
FLEXICAIR
K863047 · IOQ
Ssi Medical Services, Inc.
Physical Medicine · 24d
Cleared Sep 05, 1986
BOWEN SUTURE PASSER
K863146 · HXI
Bowen & Company, Inc.
Orthopedic · 21d
Cleared Sep 05, 1986
GLENOID DRILL
K863147 · HTW
Bowen & Company, Inc.
Orthopedic · 21d
Cleared Sep 05, 1986
BOWEN KNOT PASSER
K863148 · HXI
Bowen & Company, Inc.
Orthopedic · 21d
Cleared Sep 05, 1986
BOWEN PROBE
K863149 · HXB
Bowen & Company, Inc.
Orthopedic · 21d
Cleared Sep 05, 1986
BOWEN CANNULA
K863150 · GEA
Bowen & Company, Inc.
General & Plastic Surgery · 21d
Cleared Sep 05, 1986
TABLE, OPERATING ROOM, HYDRAULIC
K863161 · FWW
Kamiya Tsusan Kaisha, Ltd.
General & Plastic Surgery · 18d
Cleared Sep 05, 1986
MODEL 617D
K863303 · LDD
Quinton, Inc.
Cardiovascular · 11d
Cleared Sep 05, 1986
TRIAD IMPACT
K863324 · EBI
Dentsply Intl.
Dental · 9d
Cleared Sep 04, 1986
CILCO SONOMETRICS DIGICON
K854653 · IYO
CooperVision, Inc.
Radiology · 289d
Cleared Sep 04, 1986
D-DI TEST KIT
K861973 · GHH
American Bioproducts Co.
Hematology · 106d
Cleared Sep 04, 1986
MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)
K862150 · EWG
Directed Energy, Inc.
Ear, Nose, Throat · 92d