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
80257–80280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 2000
INFUSOMAT P
K003029 · FRN
B.Braun Medical, Inc.
General Hospital · 67d
Cleared Dec 04, 2000
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100...
K003245 · FOZ
Baxter Healthcare Corp
General Hospital · 48d
Cleared Dec 04, 2000
FERMIT PLUS
K003374 · EBG
Ivoclar North America, Inc.
Dental · 35d
Cleared Dec 04, 2000
FERMIT N PLUS
K003377 · EBG
Ivoclar North America, Inc.
Dental · 35d
Cleared Dec 04, 2000
CLEARGLIDE PRECISION BIPOLAR DEVICE
K003587 · GEI
Ethicon, Inc.
General & Plastic Surgery · 13d
Cleared Dec 04, 2000
U1 HIP SYSTEM
K994078 · LPH
United Orthopedic Corp.
Orthopedic · 368d
Cleared Dec 01, 2000
3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING
K002807 · IYO
Acuson Corp.
Radiology · 84d
Cleared Dec 01, 2000
MEDCOMP BIO-CATH CATHETER LINE
K003110 · LJS
Medcomp
General Hospital · 58d
Cleared Dec 01, 2000
SIREMOBIL ISO-C 3D
K003266 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 44d
Cleared Dec 01, 2000
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
K003276 · LIT
NuMED, Inc.
Cardiovascular · 43d
Cleared Dec 01, 2000
WIRECLIP TORQUER
K003398 · DQX
Boston Scientific Corporation...
Cardiovascular · 30d
Cleared Dec 01, 2000
DEPUY C-STEM SYSTEM
K003421 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Dec 01, 2000
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
K003445 · FIB
Fresenius Medical Care North America
Gastroenterology & Urology · 25d
Cleared Dec 01, 2000
PENTRA 5D
K003534 · JPK
R&D Systems, Inc.
Hematology · 15d
Cleared Nov 30, 2000
KARL STORZ HYSTEROMAT II
K000806 · HIG
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 262d
Cleared Nov 30, 2000
OS-2000 OPTICAL SONOGRAPHY SYSTEM
K001510 · NCS
Advanced Diagnostics, Inc.
Radiology · 199d
Cleared Nov 30, 2000
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION)...
K002493 · DTM
Cobe Cardiovascular, Inc.
Cardiovascular · 108d
Cleared Nov 30, 2000
TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
K002740 · JWH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Nov 30, 2000
NICOLET VASOGUARD
K002766 · JOP
Nicolet Biomedical
Cardiovascular · 86d
Cleared Nov 30, 2000
COLTENE AURA COMPOMER RESTORATIVE SYSTEM
K003034 · EBF
Coltene/Whaledent, Inc.
Dental · 63d
Cleared Nov 30, 2000
FASTPACK CALIBRATORS
K003096 · JIT
Qualigen, Inc.
Immunology · 58d
Cleared Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506
K003239 · JJS
Bio-Rad
Chemistry · 44d
Cleared Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623
K003242 · JJS
Bio-Rad
Chemistry · 44d
Cleared Nov 30, 2000
V-40/C-TAPER ADAPTER SLEEVE
K003379 · LZO
Howmedica Osteonics Corp.
Orthopedic · 30d