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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
149065–149088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 1985
THROMBINEX BOVINE THROMBIN
K845000 · GJA
Bio/Data Corp.
Hematology · 90d
Cleared Mar 26, 1985
CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER
K845019 · GKL
Abbott Diagnostics
Hematology · 89d
Cleared Mar 26, 1985
MULTI-SIZE CASSETTE HOLDER
K850125 · IXY
Philips Medical Systems (Cleveland),...
Radiology · 71d
Cleared Mar 26, 1985
IRIDIUM 192 WIRES
K850163 · IWA
Syncor Intl. Corp.
Radiology · 69d
Cleared Mar 26, 1985
FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS
K850208 · IXD
Syncor Intl. Corp.
Radiology · 67d
Cleared Mar 26, 1985
API UNISCEPT KB
K850347 · LTW
Analytical Products, Inc.
Microbiology · 57d
Cleared Mar 26, 1985
ORBITOR II COUNTER BALANCE CAMERA
K850397 · IYX
Siemens Gammasonics, Inc.
Radiology · 53d
Cleared Mar 26, 1985
CS137 SEALED SOURCES
K850434 · KXK
Syncor Intl. Corp.
Radiology · 50d
Cleared Mar 26, 1985
I-125 IMPLANT GUN
K850571 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 41d
Cleared Mar 26, 1985
SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY
K850614 · IZH
S & S X-Ray Products, Inc.
Radiology · 39d
Cleared Mar 26, 1985
WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD
K850726 · IWA
Syncor Intl. Corp.
Radiology · 32d
Cleared Mar 26, 1985
SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY
K850787 · CGI
Nms Pharmaceuticals, Inc.
Chemistry · 28d
Cleared Mar 25, 1985
TBI TRAINER
K840837 · FEJ
Manico
Gastroenterology & Urology · 395d
Cleared Mar 25, 1985
UTAH DISPOSABLE PRESSURE TRANSDUCER
K841788 · DRS
Utah Medical Products, Inc.
Cardiovascular · 329d
Cleared Mar 25, 1985
PRESSURE MONITORING KIT
K842352 · DRS
Utah Medical Products, Inc.
Cardiovascular · 283d
Cleared Mar 25, 1985
LIMI ALLOY
K844653 · EJJ
G-C Intl. Corp.
Dental · 116d
Cleared Mar 25, 1985
KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI
K844662 · EBF
Kerr Corporation (Danbury)
Dental · 115d
Cleared Mar 25, 1985
RESUSCITATOR, PULMONARY, MANUAL
K844729 · BTM
Life Design Systems, Inc.
Anesthesiology · 111d
Cleared Mar 25, 1985
ESPE KETAC-CEM RADIOPAQUE
K844846 · EMA
Espe GmbH (Us)
Dental · 102d
Cleared Mar 25, 1985
STORZ/URBAN SURGICAL MICROSCOPE SYSTEM
K844858 · EPT
Storz Instrument Co.
General & Plastic Surgery · 101d
Cleared Mar 25, 1985
DUALLOR R SOLDER
K844867 · EJT
Degussa Dental, Inc.
Dental · 101d
Cleared Mar 25, 1985
BODY HEARING AIDS MT 80 SP
K850185 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
BOSCH STARR 66PP -HEARING AIDS
K850187 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
BOSCH STAR 66PP-S HEARING AID
K850189 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 66d