FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

Filters: Cleared only ×
175,230 results
38881–38904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 18, 2013
EARLYSENSE
K131379 · BZQ
Earlysense, Ltd.
Anesthesiology · 218d
Cleared Dec 18, 2013
COPRA TEMP PMMA-DISK
K131664 · EBG
White Peaks Dental Systems GmbH & Co. KG
Dental · 194d
Cleared Dec 18, 2013
SURGEN U
K131758 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 184d
Cleared Dec 18, 2013
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
K132186 · HKI
Optomed OY
Ophthalmic · 156d
Cleared Dec 18, 2013
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
K132418 · JGS
Roche Diagnostics
Chemistry · 138d
Cleared Dec 18, 2013
ARIX HAND LOCKING SYSTEM
K132876 · HRS
Jeil Medical Corporation
Orthopedic · 96d
Cleared Dec 18, 2013
M.U.S.T. EXTENSION
K132878 · NKB
Medacta International
Orthopedic · 96d
Cleared Dec 18, 2013
TI STAR IMPLANT SYSTEM
K132992 · DZE
T-Plus Implant Tech. Co., Ltd.
Dental · 85d
Cleared Dec 18, 2013
AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION
K133440 · HWC
Stryker Trauma AG
Orthopedic · 36d
Cleared Dec 18, 2013
APTUS CANNULATED COMPRESSION SCREWS
K133460 · HWC
Medartis AG
Orthopedic · 36d
Cleared Dec 18, 2013
VISI MOBILE MONITIORING SYSTEM
K133586 · MWI
Sotera Wireless, Inc.
Cardiovascular · 27d
Cleared Dec 18, 2013
ALERE INFLUENZA A & B TEST
K133637 · PSZ
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 41d
Cleared Dec 17, 2013
VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
K130652 · OQG
Consensus Orthopedics, Inc.
Orthopedic · 280d
Cleared Dec 17, 2013
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
K130736 · LRC
Helix Medical, LLC
Ear, Nose, Throat · 274d
Cleared Dec 17, 2013
ZOLL EPCR IOS
K131919 · DXJ
ZOLL Medical Corporation
Cardiovascular · 174d
Cleared Dec 17, 2013
PERFIX ILIAC SCREW SYSTEM
K132218 · MNH
U&I Corporation
Orthopedic · 153d
Cleared Dec 17, 2013
PRIMADO2 TOTAL SURGICAL SYSTEM
K132264 · HBC
Nakanishi, Inc.
Neurology · 148d
Cleared Dec 17, 2013
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP...
K132340 · FEQ
Erbe USA, Inc.
Gastroenterology & Urology · 144d
Cleared Dec 17, 2013
CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS
K132996 · KXK
Isoray, Inc.
Radiology · 84d
Cleared Dec 17, 2013
IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2...
K133079 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 78d
Cleared Dec 17, 2013
MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+...
K133188 · NKB
Stryker Spine
Orthopedic · 61d
Cleared Dec 17, 2013
OPTION ELITE VENA CAVA FILTER SYSTEM
K133243 · DTK
Rex Medical, L.P.
Cardiovascular · 56d
Cleared Dec 17, 2013
ZIMMER DISTAL RADIUS PLATING SYSTEM
K133246 · HRS
Zimmer, Inc.
Orthopedic · 56d
Cleared Dec 17, 2013
ST360 DEGREES SPINAL FIXATION SYSTEM
K133291 · NKB
Zimmer Spine, Inc.
Orthopedic · 53d