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
85921–85944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1999
BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471
K984223 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 154d
Cleared Apr 28, 1999
KERAVISION VACUUM RING SYSTEM
K984540 · HNO
Keravision, Inc.
Ophthalmic · 128d
Cleared Apr 28, 1999
MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012,...
K990333 · GWG
Medtronic PS Medical
Neurology · 84d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SM/RNP ELISA
K990624 · LKO
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SM ELISA
K990625 · LKP
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SS-B/LA ELISA
K990626 · LLL
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SS-A/RO ELISA
K990627 · LLL
Cogent Diagnotics , Ltd.
Immunology · 62d
Cleared Apr 28, 1999
DAUM NEUROGATE TROCAR
K990782 · KNW
Daum GmbH
Gastroenterology & Urology · 50d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA
K990796 · MOB
Cogent Diagnotics , Ltd.
Immunology · 49d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-SCL-70 ELISA
K990797 · LLL
Cogent Diagnotics , Ltd.
Immunology · 49d
Cleared Apr 28, 1999
AUTOSTAT II ANTI-JO-1 ELISA
K990798 · LLL
Cogent Diagnotics , Ltd.
Immunology · 49d
Cleared Apr 28, 1999
QUICKCARD HCG COMBO TEST, MODEL #9014
K991095 · JHI
Phamatech
Chemistry · 27d
Cleared Apr 28, 1999
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K991411 · BZQ
Gereonics, Inc.
Anesthesiology · 33d
Cleared Apr 27, 1999
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K983711 · JWY
Dade Microscan, Inc.
Microbiology · 188d
Cleared Apr 27, 1999
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K990422 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 75d
Cleared Apr 27, 1999
LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING
K990468 · LYY
Top Glove Sdn. Bhd.
General Hospital · 70d
Cleared Apr 27, 1999
X-TIP INTRAOSSEOUS PERFORATOR
K990511 · DZM
Schiff & Co.
Dental · 68d
Cleared Apr 27, 1999
PILLING WECK SURGICAL Y STENT FORCEPS
K990547 · EOQ
Pilling Weck, Inc.
Ear, Nose, Throat · 64d
Cleared Apr 27, 1999
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10
K990610 · JJY
Bio-Rad
Chemistry · 62d
Cleared Apr 27, 1999
REDI-TEST THC
K990870 · LDJ
Redwood Biotech, Inc.
Toxicology · 42d
Cleared Apr 27, 1999
MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH,...
K990947 · GEX
Lumenis, Inc.
General & Plastic Surgery · 36d
Cleared Apr 27, 1999
EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816
K990971 · JJR
Medica Corp.
Chemistry · 35d
Cleared Apr 27, 1999
MODIFICATION OF: DAVIDSTRIP HCG
K991067 · JHI
Simex Medical, Inc.
Chemistry · 28d
Cleared Apr 27, 1999
MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5
K991277 · DDR
Diagnostic Products Corp.
Chemistry · 13d