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
100033–100056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 1995
JACOBYSCOPE
K953912 · EIA
Perioview, Inc.
Dental · 86d
Cleared Nov 15, 1995
SIME SURGICAL POWDERFREE
K954025 · KGO
Sime Health, Ltd.
General Hospital · 79d
Cleared Nov 15, 1995
SIME POWDERFREE PLUS
K954051 · LYY
Sime Health, Ltd.
General Hospital · 78d
Cleared Nov 15, 1995
UNITRAX V40 MODULAR ADAPTOR
K954077 · KWL
Howmedica Corp.
Orthopedic · 77d
Cleared Nov 15, 1995
GLANZ CARCINOMA GAUGE, KSEA
K954348 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 58d
Cleared Nov 15, 1995
VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM
K954433 · LJT
Gish Biomedical, Inc.
General Hospital · 51d
Cleared Nov 15, 1995
HYDROCELL NASAL AND SINUS PACKS
K954491 · EMX
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 49d
Cleared Nov 15, 1995
THERMALASTIC/TRIPOLYVINALENE
K954662 · ELW
Tak Systems
Dental · 36d
Cleared Nov 15, 1995
AT2 & DOYLE STYLE (C-FLEX) VENT TUBES
K954795 · ETD
Trebay Medical Corp.
Ear, Nose, Throat · 28d
Cleared Nov 15, 1995
DW260 19
K954837 · EJT
Ivoclar North America, Inc.
Dental · 26d
Cleared Nov 15, 1995
AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA
K954876 · EMA
American Dental Products, Inc.
Dental · 22d
Cleared Nov 15, 1995
LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION)
K954880 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 29d
Cleared Nov 14, 1995
ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT
K933878 · GKZ
Intracel Corp.
Hematology · 827d
Cleared Nov 14, 1995
PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)
K940001 · IYE
Nucletron Corp.
Radiology · 680d
Cleared Nov 14, 1995
DOC'S PROPLUGS EAR PLUGS
K945376 · EWD
Doc'S Proplugs, Inc.
Ear, Nose, Throat · 389d
Cleared Nov 14, 1995
NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER
K945578 · DRG
Nihon Kohden America, Inc.
Cardiovascular · 365d
Cleared Nov 14, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM
K950472 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 284d
Cleared Nov 14, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540
K950475 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 284d
Cleared Nov 14, 1995
CLINICAL PROTON SPECTROSCOPY OPTION
K951650 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 218d
Cleared Nov 14, 1995
AURAFLEX TESTOSTERONE CALIBRATOR PACK
K951685 · CDZ
Organon Teknika Corp.
Chemistry · 218d
Cleared Nov 14, 1995
GE B510 TRANSDUCER
K951723 · ITX
GE Medical Systems
Radiology · 214d
Cleared Nov 14, 1995
XXL BALLON DILATATION CATHETER
K952063 · LIT
Boston Scientific Corp
Cardiovascular · 196d
Cleared Nov 14, 1995
LYOFOAM EXTRA
K952565 · KMF
Acme United Corp.
General & Plastic Surgery · 165d
Cleared Nov 14, 1995
LOKKI DT
K952682 · GEX
Lokki
General & Plastic Surgery · 155d