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
76345–76368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2002
DADE THROMBOPLASTIN C PLUS
K013155 · GJS
Dade Behring, Inc.
Hematology · 119d
Cleared Jan 18, 2002
USA SERIES LAPAROSCOPES
K013165 · GCJ
Circon Acmi
General & Plastic Surgery · 119d
Cleared Jan 18, 2002
3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR
K013228 · JOJ
Minnesota Mining and Mfg. Co.
General Hospital · 113d
Cleared Jan 18, 2002
3.75MM AND 5.0MM SPLINE TWIST IMPLANT
K013494 · DZE
Sulzer Dental, Inc.
Dental · 88d
Cleared Jan 18, 2002
POINT 4 MODIFIED
K013510 · EBF
Sybron Dental Specialties, Inc.
Dental · 88d
Cleared Jan 18, 2002
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
K013518 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 87d
Cleared Jan 18, 2002
EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)
K013533 · DRG
General Devices
Cardiovascular · 87d
Cleared Jan 18, 2002
EVTOOL MODEL # V. 1.0
K013535 · MUJ
3D Line USA, Inc.
Radiology · 87d
Cleared Jan 18, 2002
PLLA CANNULATED INTERFERENCE SCREW
K013685 · HWC
Future Medical Systems, Inc.
Orthopedic · 72d
Cleared Jan 18, 2002
ADVIA 1650 CHOLINESTERASE ASSAY
K013750 · DIH
Bayer Diagnostics Corp.
Chemistry · 66d
Cleared Jan 18, 2002
MODIFICATION TO: WINNER ST-2 STIMULATOR
K013770 · IPF
Rich-Mar Corp.
Physical Medicine · 66d
Cleared Jan 18, 2002
MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND...
K013771 · IPF
Rich-Mar Corp.
Physical Medicine · 66d
Cleared Jan 18, 2002
AUTION MAX AX-4280 URINALYSIS SYSTEM
K013783 · KQO
International Remote Imaging Systems
Chemistry · 65d
Cleared Jan 18, 2002
TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
K013894 · MOS
Philips Medical Systems North...
Radiology · 56d
Cleared Jan 18, 2002
CREATINE KINASE (CK-NAC)
K013912 · CGS
Jas Diagnostics, Inc.
Chemistry · 52d
Cleared Jan 18, 2002
PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM
K014159 · DSI
Philips Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jan 18, 2002
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K014184 · FGE
Guidant Corp.
Gastroenterology & Urology · 29d
Cleared Jan 18, 2002
PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS
K014209 · MKJ
Padpro, LLC
Cardiovascular · 28d
Cleared Jan 18, 2002
ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD
K014222 · GEI
Arthrocare Corp.
General & Plastic Surgery · 23d
Cleared Jan 18, 2002
BIO SPA INTELLIGENT
K992099 · IPF
Starbene
Physical Medicine · 942d
Cleared Jan 17, 2002
BIOLIGHT PCD
K011355 · ILY
Biolight International AB
Physical Medicine · 259d
Cleared Jan 17, 2002
RANDOX THEOPHYLLINE
K011771 · KLS
Randox Laboratories, Ltd.
Chemistry · 225d
Cleared Jan 17, 2002
DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C
K011839 · EBF
Doxa Certex AB
Dental · 219d
Cleared Jan 17, 2002
ECG HOME
K012012 · DXH
H&C Medical Devices Spa
Cardiovascular · 203d