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
100609–100632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 1995
DIASTAT VASCULAR ACCESS GRAFT
K953288 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 84d
Cleared Oct 06, 1995
TOX PERFECT A TUBE
K953393 · DMP
Chimera Research & Chemical, Inc.
Chemistry · 84d
Cleared Oct 06, 1995
UNISCAN
K953398 · LMD
Merlin Engineering Works, Inc.
Radiology · 78d
Cleared Oct 06, 1995
DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS
K953403 · KMF
Deroyal Industries, Inc.
General & Plastic Surgery · 78d
Cleared Oct 06, 1995
SAUER ENDOSCOPE GUIDE AND INTUBATION AID
K954125 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 06, 1995
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K954137 · JPK
R&D Systems, Inc.
Hematology · 35d
Cleared Oct 06, 1995
OPUS HCG CONTROLS
K954144 · JJX
Behring Diagnostics, Inc.
Chemistry · 31d
Cleared Oct 06, 1995
HOLLISTER HYDROCOLLOID WOUND DRESSING
K954235 · FRO
Hollister, Inc.
General & Plastic Surgery · 25d
Cleared Oct 06, 1995
ANGIOREX
K954309 · IZI
Toshiba Medical Systems
Radiology · 21d
Cleared Oct 06, 1995
UNITRON MODEL SOUND F/X
K954430 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 14d
Cleared Oct 05, 1995
W&H 900 INCOLIGHT LT HANDPIECE
K944718 · EFB
A-Dec, Inc.
Dental · 377d
Cleared Oct 05, 1995
W&H 100 SERIES LOW SPEED
K944719 · EFB
A-Dec, Inc.
Dental · 377d
Cleared Oct 05, 1995
IOLAB/SITE PERISTALTIC MODULE
K944995 · HQC
Chiron Vision Corp.
Ophthalmic · 358d
Cleared Oct 05, 1995
W&H ROTO QUICK COUPLINGS
K945734 · EFB
A-Dec, Inc.
Dental · 316d
Cleared Oct 05, 1995
THERMOTEK H-300
K945853 · ILO
Thermotek, Inc.
Physical Medicine · 339d
Cleared Oct 05, 1995
POSITIVE LUPUS ANTICOAGULANT PLASMA
K945856 · GGC
George King Bio-Medical, Inc.
Hematology · 325d
Cleared Oct 05, 1995
WAKO AUTOKIT GLUCOSE
K950172 · CGA
Wako Chemicals USA, Inc.
Chemistry · 261d
Cleared Oct 05, 1995
CATHETER, BALLOON TYPE
K950398 · DQO
Interventional Therapeutics Corp.
Cardiovascular · 246d
Cleared Oct 05, 1995
FLEXMATE K500
K950755 · BXB
Breg, Inc.
Physical Medicine · 230d
Cleared Oct 05, 1995
CARDIMA, INC. FORERUNNER
K951603 · DQY
Cardima, Inc.
Cardiovascular · 181d
Cleared Oct 05, 1995
EXTERNAL FIXATOR
K952330 · JEC
Acu Med, Inc.
Orthopedic · 140d
Cleared Oct 05, 1995
CARBON DIOXIDE - DST
K952410 · KHS
Trace America, Inc.
Chemistry · 134d
Cleared Oct 05, 1995
KARL STORZ FLEXIBLE HYSTERSCOPE
K952779 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 111d
Cleared Oct 05, 1995
ALTRA FLUX 110 HEMODIALYZER
K952978 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 100d