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
76609–76632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2001
POLARUS CAP SCREW
K013616 · HSB
Acu Med, Inc.
Orthopedic · 44d
Cleared Dec 19, 2001
PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K013798 · DZE
Institut Straumann AG
Dental · 34d
Cleared Dec 19, 2001
XIA SPINAL SYSTEM
K013823 · KWP
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Dec 19, 2001
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Dec 19, 2001
AUTO SUTURE SURGICAL STAPLES
K013860 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 28d
Cleared Dec 19, 2001
CODMAN SLIM-LOC SYSTEM
K013877 · KWQ
Codman & Shurtleff, Inc.
Orthopedic · 26d
Cleared Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989 · LZO
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Dec 19, 2001
GENERATION 4 BONE CEMENT
K993836 · LOD
Biomet, Inc.
Orthopedic · 768d
Cleared Dec 18, 2001
SHAPEABLE DOPPLER FLOW PROBE
K002958 · ITX
Cook Vascular, Inc.
Radiology · 452d
Cleared Dec 18, 2001
HOME-AWAY SYSTEM
K004047 · CAW
In-X Corp.
Anesthesiology · 354d
Cleared Dec 18, 2001
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
K010925 · CBK
Siemens Elema AB
Anesthesiology · 266d
Cleared Dec 18, 2001
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
K011907 · DWJ
Sims Level 1, Inc.
Cardiovascular · 183d
Cleared Dec 18, 2001
RAMP MYOGLOBIN ASSAY
K012040 · DDR
Response Biomedical Corp.
Chemistry · 172d
Cleared Dec 18, 2001
NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
K012088 · KNW
Nastech Pharmaceutical Company, Inc.
Gastroenterology & Urology · 168d
Cleared Dec 18, 2001
NO STEP ON SITE DEUG TEST CUP
K012390 · LDJ
Drug Free Enterprises
Toxicology · 144d
Cleared Dec 18, 2001
AURIS AEP
K012415 · GWJ
Synapsys, Inc.
Neurology · 141d
Cleared Dec 18, 2001
DATACAPTOR
K013019 · MWI
Capsule Technologie
Cardiovascular · 102d
Cleared Dec 18, 2001
STELLARTECH COAGULATION SYSTEM
K013139 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 90d
Cleared Dec 18, 2001
DC-UIBC-CO2-CAL, MODEL SE-153
K013178 · JIX
Diagnostic Chemicals , Ltd.
Chemistry · 85d
Cleared Dec 18, 2001
SPIRIT 300
K013251 · BYJ
Caire, Inc.
Anesthesiology · 81d
Cleared Dec 18, 2001
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
K013380 · DJG
ACON Laboratories, Inc.
Toxicology · 67d
Cleared Dec 18, 2001
ADVIA CENTAUR HOMOCYSTEINE ASSAY
K013406 · LPS
Bayer Diagnostics Corp.
Chemistry · 64d
Cleared Dec 18, 2001
PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
K013451 · CGZ
Phoenix Diagnostics, Inc.
Chemistry · 61d
Cleared Dec 18, 2001
INVERNESS MEDICAL EARLY PREGNANCY TEST
K013907 · LCX
Cambridge Diagnostics Ireland, Ltd.
Chemistry · 22d