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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
85825–85848 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1999
GLUCOMETER ELITE TEST STRIPS
K991242 · CGA
Bayer Corp.
Chemistry · 79d
Cleared Jun 30, 1999
COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES
K991282 · LMC
Seiko Instruments USA, Inc.
Radiology · 77d
Cleared Jun 30, 1999
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K991576 · CIX
Bayer Corp.
Chemistry · 55d
Cleared Jun 30, 1999
CHIRON DIAGNOSTICS ACS: 180 FOLATE
K991582 · CGN
Chiron Diagnostics Corp.
Immunology · 54d
Cleared Jun 30, 1999
AST/SGOT
K991663 · CIT
A.P. Total Care, Inc.
Chemistry · 47d
Cleared Jun 30, 1999
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
K991666 · JMO
A.P. Total Care, Inc.
Chemistry · 47d
Cleared Jun 30, 1999
MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL
K992033 · DKZ
American Bio Medica Corp.
Toxicology · 14d
Cleared Jun 29, 1999
FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
K984586 · DTN
Fresenius Hemotechnology, Inc.
Cardiovascular · 187d
Cleared Jun 29, 1999
AMIB7
K990198 · IYO
Alliance Medical, Inc.
Radiology · 159d
Cleared Jun 29, 1999
GYRUS ENDOUROLOGY SYSTEM
K990628 · KNS
Gyrus Medical , Ltd.
Gastroenterology & Urology · 124d
Cleared Jun 29, 1999
SHADOW TRAYS
K991107 · IYE
Mick Radio-Nuclear Instruments, Inc.
Radiology · 89d
Cleared Jun 29, 1999
O.B. APPLICATOR TAMPONS, O.B. TAMPONS
K991118 · HEB
Personal Products Co.
Obstetrics & Gynecology · 89d
Cleared Jun 29, 1999
K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23,...
K991229 · MQG
Henning Knudsen Engineering A/S
Obstetrics & Gynecology · 78d
Cleared Jun 29, 1999
SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
K991287 · FRO
Advanced Medical Solutions Group Plc
General & Plastic Surgery · 76d
Cleared Jun 29, 1999
COAGULOOP
K991314 · FAS
American Medical Systems, Inc.
Gastroenterology & Urology · 74d
Cleared Jun 29, 1999
OMNI-FIX, HUMERAL NAIL
K991405 · KTW
Turnkey Intergration USA, Inc.
Orthopedic · 68d
Cleared Jun 29, 1999
ORIBRUSH - STANDARD - B002
K991593 · HHT
Orifice Medical AB
Obstetrics & Gynecology · 53d
Cleared Jun 29, 1999
ORIBRUSH - WITH PROTECTIVE TIP - B001
K991595 · HHT
Orifice Medical AB
Obstetrics & Gynecology · 53d
Cleared Jun 29, 1999
GRIT BLASTED HUMERAL STEM
K991603 · KWT
Encore Orthopedics, Inc.
Orthopedic · 50d
Cleared Jun 29, 1999
FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX...
K991780 · HQD
G.T. Laboratories, Inc.
Ophthalmic · 35d
Cleared Jun 29, 1999
FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS
K991781 · HQD
G.T. Laboratories, Inc.
Ophthalmic · 35d
Cleared Jun 29, 1999
OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS
K991952 · LZO
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Jun 29, 1999
W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55...
K992010 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 14d
Cleared Jun 28, 1999
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE
K984162 · MAH
Nobelpharma USA, Inc.
Ear, Nose, Throat · 221d