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
79729–79752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2001
ADVIA 120 HEMATOLOGY
K003796 · GKZ
Bayer Corp.
Hematology · 59d
Cleared Feb 05, 2001
INTRAVASCULAR ADMINISTRATION SET
K003854 · FPA
Infusion Devices, Inc.
General Hospital · 54d
Cleared Feb 05, 2001
LIVESURE THC SCREEN TEST
K010001 · LDJ
Pan Probe Biotech, Inc.
Toxicology · 34d
Cleared Feb 05, 2001
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
K010050 · CGN
Bayer Diagnostics Corp.
Chemistry · 31d
Cleared Feb 05, 2001
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
K010081 · KWY
Exactech, Inc.
Orthopedic · 26d
Cleared Feb 05, 2001
MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841
K993600 · LIH
Nisha Communication Industries
Neurology · 469d
Cleared Feb 02, 2001
SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS
K001965 · FMI
North American Medical Products, Inc.
General Hospital · 219d
Cleared Feb 02, 2001
ACE SDS 3.75MM SCREW DENTAL IMPLANT
K002075 · DZE
Ace Surgical Supply Co., Inc.
Dental · 207d
Cleared Feb 02, 2001
WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE
K002219 · GXY
Wandy Rubber Industrial Co., Ltd.
Neurology · 193d
Cleared Feb 02, 2001
WANDY SILICONE CONDUCTIVE RUBBER PAD
K002227 · GXY
Wandy Rubber Industrial Co., Ltd.
Neurology · 193d
Cleared Feb 02, 2001
P3IMRT TM
K002237 · MUJ
Adac Laboratories
Radiology · 193d
Cleared Feb 02, 2001
EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
K002407 · JGS
Medica Corp.
Chemistry · 179d
Cleared Feb 02, 2001
SELECT SEED I-125
K002429 · KXK
Nucletron Corp.
Radiology · 178d
Cleared Feb 02, 2001
SURGI-VISION GUIDEWIRE COIL
K003436 · MOS
Surgi-Vision, Inc.
Radiology · 88d
Cleared Feb 02, 2001
ODYSSEY LX, MODEL 211320
K003437 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Feb 02, 2001
NEXT GENERAL M20 SURGICAL LIGHT
K003489 · FSS
Medical Illumination International, Inc.
General & Plastic Surgery · 81d
Cleared Feb 02, 2001
PORTALVISION
K003636 · IYE
Varian Medical Systems, Inc.
Radiology · 70d
Cleared Feb 02, 2001
PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K003655 · MOS
Mri Devices Corp.
Radiology · 67d
Cleared Feb 02, 2001
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048
K003710 · FET
Smith & Nephew, Inc.
Gastroenterology & Urology · 63d
Cleared Feb 02, 2001
CLEAN SCRAPE
K003773 · GEI
Webb Research Ii, Inc.
General & Plastic Surgery · 58d
Cleared Feb 02, 2001
OPDIMA
K003945 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Feb 02, 2001
X-RAY SYSTEM XR-MX
K004037 · JAA
Karl Storz Endoscopy
Radiology · 36d
Cleared Feb 02, 2001
MODIFICATION TO ARTOSCAN M
K010057 · LNH
Biosound Esaote, Inc.
Radiology · 25d
Cleared Feb 02, 2001
ANALGESIC PULSER, MODEL AP-439
K993229 · GZJ
Johari Electro-Tech Co.
Neurology · 494d