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
114217–114240 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1993
PHILIPS TOMOSCAN SR7000 CT SYSTEMS
K924082 · JAK
Philips Medical Systems, Inc.
Radiology · 209d
Cleared Mar 10, 1993
700/700-1
K924083 · CCK
Citicare Systems, Inc.
Anesthesiology · 209d
Cleared Mar 10, 1993
DANTEC EVOLUTION
K924127 · GWF
Dantec Medical, Inc.
Neurology · 205d
Cleared Mar 10, 1993
THAYER HAND HELD M.K.I. HOLDING CHAMBER
K924535 · CAF
Thayer Medical Corp.
Anesthesiology · 183d
Cleared Mar 10, 1993
ACA DIGOXIN ANALYTICAL TEST PACK
K930162 · KXT
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 56d
Cleared Mar 10, 1993
HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE
K930247 · DHC
The Binding Site, Ltd.
Immunology · 50d
Cleared Mar 10, 1993
ELIAS DSDNA ABS
K930421 · DHC
Elias U.S.A., Inc.
Immunology · 43d
Cleared Mar 10, 1993
TINA-QUANT CRP
K930621 · DCK
Boehringer Mannheim Corp.
Immunology · 30d
Cleared Mar 09, 1993
SONOPULS 590
K920983 · IMI
Henley Intl.
Physical Medicine · 372d
Cleared Mar 09, 1993
ADAP-TEMP TEMPERATURE SENSOR ADAPTER
K921190 · FLL
Respiratory Support Products, Inc.
General Hospital · 365d
Cleared Mar 09, 1993
ULTRA III
K921952 · IMG
Excel Tech. , Ltd.
Physical Medicine · 316d
Cleared Mar 09, 1993
FIBRINOGEN RID TEST KIT
K922416 · KQJ
The Binding Site, Ltd.
Hematology · 292d
Cleared Mar 09, 1993
COMPEL XTR
K922753 · FYA
Standard Textile Co., Inc.
General Hospital · 274d
Cleared Mar 09, 1993
SENSITITRE SUSCEPTIBILITY PLATES
K923045 · JWY
Radiometer America, Inc.
Microbiology · 258d
Cleared Mar 09, 1993
ULTRA SX
K923076 · IMI
Excel Tech. , Ltd.
Physical Medicine · 257d
Cleared Mar 09, 1993
CALIBRATION VERIFICATION KIT OR CVK
K924802 · JJY
Radiometer America, Inc.
Chemistry · 166d
Cleared Mar 09, 1993
FEMORAL & TIBIAL AUGMENT BLOCK
K924940 · JWH
Joint Medical Products Corp.
Orthopedic · 160d
Cleared Mar 09, 1993
QA PRESSURE MEASUREMENT SYSTEM
K925052 · JFC
Gabel Medical Instruments, Ltd.
Physical Medicine · 154d
Cleared Mar 09, 1993
DYNAMIC PRESSURE MONITOR 2000M AND 2000C
K925258 · JFC
Pin Dot Products, Inc.
Physical Medicine · 141d
Cleared Mar 09, 1993
SLASE 210 PLUS HOLMIUM LASER SYSTEM
K925549 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 126d
Cleared Mar 09, 1993
THERAPACER 3000
K925666 · BXB
Kvm Technologies, Inc.
Physical Medicine · 119d
Cleared Mar 09, 1993
MCKERNAN-ADSON AGGRESSIVE FORCEPS
K926281 · GCJ
Aslan Medical Technologies, Ltd.
General & Plastic Surgery · 85d
Cleared Mar 09, 1993
MCKERNAN-POTTS GRASPING FORCEPS
K926282 · GCJ
Aslan Medical Technologies, Ltd.
General & Plastic Surgery · 85d
Cleared Mar 08, 1993
FLOW CONROL VALVE
K922781 · MJJ
American Omni Medical, Inc.
Cardiovascular · 272d