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.

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

Filters: Cleared only ×
175,230 results
142537–142560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 1986
GLENOID DRILL
K863147 · HTW
Bowen & Company, Inc.
Orthopedic · 21d
Cleared Sep 05, 1986
BOWEN KNOT PASSER
K863148 · HXI
Bowen & Company, Inc.
Orthopedic · 21d
Cleared Sep 05, 1986
BOWEN PROBE
K863149 · HXB
Bowen & Company, Inc.
Orthopedic · 21d
Cleared Sep 05, 1986
BOWEN CANNULA
K863150 · GEA
Bowen & Company, Inc.
General & Plastic Surgery · 21d
Cleared Sep 05, 1986
TABLE, OPERATING ROOM, HYDRAULIC
K863161 · FWW
Kamiya Tsusan Kaisha, Ltd.
General & Plastic Surgery · 18d
Cleared Sep 05, 1986
MODEL 617D
K863303 · LDD
Quinton, Inc.
Cardiovascular · 11d
Cleared Sep 05, 1986
TRIAD IMPACT
K863324 · EBI
Dentsply Intl.
Dental · 9d
Cleared Sep 04, 1986
CILCO SONOMETRICS DIGICON
K854653 · IYO
CooperVision, Inc.
Radiology · 289d
Cleared Sep 04, 1986
D-DI TEST KIT
K861973 · GHH
American Bioproducts Co.
Hematology · 106d
Cleared Sep 04, 1986
MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)
K862150 · EWG
Directed Energy, Inc.
Ear, Nose, Throat · 92d
Cleared Sep 04, 1986
MODIFIED BIO-FLOW MODEL 200 URINE FLOW DEVICE
K862251 · KNX
Bio-Flow, Inc.
Gastroenterology & Urology · 84d
Cleared Sep 04, 1986
MODEL RCV REFLUX CHECK VALVE
K862327 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 77d
Cleared Sep 04, 1986
CELLECT 8E AUTOMATED BLOOD CELL COUNTERS
K862374 · GKL
Instrumentation Laboratory CO
Hematology · 72d
Cleared Sep 04, 1986
ACS WIRE SHAPER
K862567 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 59d
Cleared Sep 04, 1986
INTERFACE ARTERIAL BLOOD FILTER, MODEL 42
K862591 · DTM
Medical, Inc.
Cardiovascular · 59d
Cleared Sep 04, 1986
INTERFACE ARTERIAL BLOOD FILTER, MODEL 44
K862609 · DTM
Medical, Inc.
Cardiovascular · 58d
Cleared Sep 04, 1986
CYTOTECH CIC ENZYME IMMUNOASSAY
K862649 · DAK
Cytotech, Inc.
Immunology · 55d
Cleared Sep 04, 1986
NOVACYTE-U
K862665 · KDT
Xsirius Medical, Inc.
Pathology · 52d
Cleared Sep 04, 1986
TINA-QUANT(R) IGA
K862763 · CZP
Boehringer Mannheim Corp.
Immunology · 44d
Cleared Sep 04, 1986
ASSERACHROM PF4 KIT
K862774 · LCO
American Bioproducts Co.
Hematology · 44d
Cleared Sep 04, 1986
HI-LO ELEVATOR FLAT TABLE
K862825 · IXQ
Garrels X-Ray Products, Inc.
Radiology · 41d
Cleared Sep 04, 1986
ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.
K862974 · DXY
Medtronic Vascular
Cardiovascular · 29d
Cleared Sep 04, 1986
COULTER COUNTER MODEL T-890
K863084 · GKL
Coulter Electronics, Inc.
Hematology · 23d
Cleared Sep 04, 1986
COULTER COUNTER MODEL T-540
K863085 · GKL
Coulter Electronics, Inc.
Hematology · 23d