FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
87361–87384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1998
VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR,...
K982212 · GEI
Synergetics, Inc.
General & Plastic Surgery · 162d
Cleared Dec 02, 1998
PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000
K983026 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 93d
Cleared Dec 02, 1998
ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE
K983279 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 75d
Cleared Dec 02, 1998
BARRON MICROKERATOME SYSTEM, MODEL B2000
K983317 · HNO
Barron Precision Instruments, LLC
Ophthalmic · 72d
Cleared Dec 02, 1998
DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER
K983491 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 58d
Cleared Dec 02, 1998
150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH
K983710 · JDI
Biomet, Inc.
Orthopedic · 42d
Cleared Dec 02, 1998
OSTEONICS RESTORATION HA HIP STEMS
K983870 · MEH
Osteonics Corp.
Orthopedic · 30d
Cleared Dec 01, 1998
CAIRD TECHNOLOGY SPIROMETER
K971336 · BZG
Caird Technology
Anesthesiology · 600d
Cleared Dec 01, 1998
VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE
K974259 · DWF
Edwards Lifesciences Research Medical
Cardiovascular · 383d
Cleared Dec 01, 1998
PERIPHERAL VASCULAR DILATOR
K974617 · DRE
Endovascular Instruments, Inc.
Cardiovascular · 355d
Cleared Dec 01, 1998
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM
K983065 · LFL
Mentor Corp.
General & Plastic Surgery · 90d
Cleared Dec 01, 1998
AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
K983072 · OLV
Nihon Kohden America, Inc.
Neurology · 90d
Cleared Dec 01, 1998
DELIVERY SHEATH
K983415 · FED
Conway Stuart Medical, Inc.
Gastroenterology & Urology · 63d
Cleared Dec 01, 1998
ABBOTT ARCHEITECT TOTAL B-HCG
K983424 · DHA
Abbott Laboratories
Chemistry · 63d
Cleared Dec 01, 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS...
K983503 · CEO
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Dec 01, 1998
MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT
K983847 · EIA
Germiphene Corp.
Dental · 32d
Cleared Dec 01, 1998
RITA MODEL 70 ELECTROSURGICAL PROBE
K983871 · GEI
Rita Medical Systems
General & Plastic Surgery · 29d
Cleared Dec 01, 1998
COAGULATION CONTROL LEVEL 1 (NORMAL)
K984129 · GIZ
Pacific Hemostasis
Hematology · 13d
Cleared Dec 01, 1998
COAGULATION CONTROL LEVEL 2 (ABNORMAL)
K984130 · GGC
Pacific Hemostasis
Hematology · 13d
Cleared Dec 01, 1998
COAGULATION CONTROL LEVEL 3 (ABNORMAL)
K984131 · GGC
Pacific Hemostasis
Hematology · 13d
Cleared Nov 30, 1998
UNISEAL GLOVES LOW PROTEIN POWDERED
K981979 · LYY
American Healthcare Products (M) Sdn Bhd
General Hospital · 178d
Cleared Nov 30, 1998
ROTECNO 2000 SURGICAL GOWN
K982059 · FYA
Encompass Group, LLC
General Hospital · 172d
Cleared Nov 30, 1998
FLUIDSENSE FLUID DELIVERY SYSTEM
K982170 · FRN
Fluidsense Corp.
General Hospital · 164d
Cleared Nov 30, 1998
NITRILE POWDER-FREE UNISEAL GLOVES
K982218 · LZA
American Healthcare Products (M) Sdn Bhd
General Hospital · 159d