FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
126073–126096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1990
VKG 1000, VIDEO KERATOGRAPH
K901523 · HJA
The Sanborn Co.
Ophthalmic · 86d
Cleared Jun 27, 1990
MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33
K901638 · GEX
Lasermatic, Inc.
General & Plastic Surgery · 79d
Cleared Jun 27, 1990
IMPROVED BAKER TWIN-CUFF SUMP TUBE
K901683 · KNT
Bissell Medical Products, Inc.
Gastroenterology & Urology · 78d
Cleared Jun 27, 1990
LIFESTYLE HOME TANNING UNITS
K901714 · LEJ
Life Products, Inc.
General & Plastic Surgery · 75d
Cleared Jun 27, 1990
SELFCATH
K901738 · KOD
Vitaid, Ltd.
Gastroenterology & Urology · 71d
Cleared Jun 27, 1990
LASEGUIDE CAT # CLF-600D & CLF-1000D
K901786 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 70d
Cleared Jun 27, 1990
DENTIN PROTECTOR
K901915 · LBH
Ivoclar North America, Inc.
Dental · 62d
Cleared Jun 27, 1990
3M LUTING CEMENT - PASTE A AND PASTE B
K902041 · EMA
3M Company
Dental · 54d
Cleared Jun 26, 1990
LIFECARE MICRO PUMP (INFUSION PUMP)
K893769 · FRN
Abbott Laboratories
General Hospital · 403d
Cleared Jun 26, 1990
AUDIOTESTER SCREENING AUDIOMETER
K894484 · EWO
Prometex, Inc.
Ear, Nose, Throat · 343d
Cleared Jun 26, 1990
MD-2 IONTOPHORESIS UNIT
K895365 · EGJ
R. A. Fischer Co. Corp.
Physical Medicine · 302d
Cleared Jun 26, 1990
PANCRETEC I.V. MODEL 5000 INFUSER
K895867 · FRN
Abbott Laboratories
General Hospital · 265d
Cleared Jun 26, 1990
COBAS READY PROFILE 2 REAGENT STRIP
K896225 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 239d
Cleared Jun 26, 1990
INTRAUTERINE INSEMINATION CATHETERS
K896960 · HDR
C.R. Bard, Inc.
Obstetrics & Gynecology · 194d
Cleared Jun 26, 1990
COBAS READY CALIBRATOR KIT
K897097 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 187d
Cleared Jun 26, 1990
NAMIC PTCA Y-ADAPTOR
K900652 · DTL
North American Instrument Corp.
Cardiovascular · 137d
Cleared Jun 26, 1990
PV-CERAMIC, CERAMINIQUE
K901261 · EIH
Ivoclar North America, Inc.
Dental · 103d
Cleared Jun 26, 1990
MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM
K901340 · GEX
Klinger Medical
General & Plastic Surgery · 96d
Cleared Jun 26, 1990
CENTREMARK(TM) CENTRAL VENOUS CATHETER TRAY
K901374
Menlo Care, Inc.
General Hospital · 96d
Cleared Jun 26, 1990
DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER
K901391 · DYB
Datascope Corp.
Cardiovascular · 92d
Cleared Jun 26, 1990
NUTRIMIX MACRO TPN COMPOUNDER
K901404 · LHI
Abbott Laboratories
General Hospital · 92d
Cleared Jun 26, 1990
WURTZ CHOLEY CLIP (TM)
K901520 · GBZ
Cd Medical, Inc.
General & Plastic Surgery · 85d
Cleared Jun 26, 1990
MODIFIED OPUS VALPROIC ACID TEST SYSTEM
K901538 · LEG
Pb Diagnostic Systems, Inc.
Toxicology · 85d
Cleared Jun 26, 1990
GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM
K901545 · JWM
Toshiba America Medical Systems, In.C
Radiology · 84d