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
119401–119424 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1991
AVI MODEL 840D DUAL CHANNEL INFUSION PUMP
K912589 · FRN
3M Avi, Inc.
General Hospital · 129d
Cleared Oct 17, 1991
AVI MODEL 400D INFUSION PUMP
K912590 · FRN
3M Avi, Inc.
General Hospital · 129d
Cleared Oct 17, 1991
MODULEX RTP SYSTEM
K913017 · KPQ
Computerized Medical Systems, Inc.
Radiology · 100d
Cleared Oct 17, 1991
I.V. INSTANT TIMER
K913076 · FPA
The Master Medical Corp.
General Hospital · 98d
Cleared Oct 17, 1991
BI-TEMP TEMPERATURE MONITOR TM-201D
K913083 · FLL
Respiratory Support Products, Inc.
General Hospital · 147d
Cleared Oct 17, 1991
MEGA MYELOGRAM KIT
K913141 · FMI
Megadyne Medical Products, Inc.
General Hospital · 93d
Cleared Oct 17, 1991
OSTEO BONE PLATED
K913271 · HRS
Fred C. Bryson
Orthopedic · 86d
Cleared Oct 17, 1991
MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS
K913288 · DTB
Medtronic Vascular
Cardiovascular · 85d
Cleared Oct 17, 1991
COMPAC A, ELITE A, ELITE A PLUS, SURGICA A
K913569 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 69d
Cleared Oct 17, 1991
PROBASE HOT AND PROBASE COLD
K913655 · EBI
Ivoclar North America, Inc.
Dental · 65d
Cleared Oct 17, 1991
3-D ACCUSCAN FACIAL IMPLANTS
K913761 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 57d
Cleared Oct 17, 1991
AUTO SUTURE(R) POWERED ENDOSCOPIC GIA(TM) STAPLER
K913802 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 52d
Cleared Oct 17, 1991
AUTO SUTURE(R) POWERED ENDOSCOPIC TA(R) STAPLER
K913832 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 52d
Cleared Oct 17, 1991
VLC GLASS IONOMER
K913836 · EMA
Dentsply Intl.
Dental · 52d
Cleared Oct 17, 1991
AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES
K914130 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 34d
Cleared Oct 17, 1991
HOMECLINIC ONE STEP PREGNANCY TEST
K914254 · LCX
Vanguard Biomedical Corp.
Chemistry · 24d
Cleared Oct 17, 1991
FIRST RESPONSE(R) ONE-STEP
K914304 · LCX
Armkel, LLC
Chemistry · 22d
Cleared Oct 17, 1991
MODELS E2502B/E2525 REUSABLE HANDSWITCHING PENCILS
K914400 · GEI
Valleylab, Inc.
General & Plastic Surgery · 15d
Cleared Oct 16, 1991
FIAX LYME M TEST KIT
K904893 · LSR
Whittaker Bioproducts, Inc.
Microbiology · 351d
Cleared Oct 16, 1991
MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
K905403 · DXY
Cook Pacemaker Corp.
Cardiovascular · 317d
Cleared Oct 16, 1991
CARD GUARD, MODELS CG-6000 & CG-7000
K910884 · DSH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 226d
Cleared Oct 16, 1991
MODEL #100 SHOCK-TRODE CHILD DEFIB PADS
K911455 · LDD
Cardiotronics, Inc.
Cardiovascular · 196d
Cleared Oct 16, 1991
MODEL #110 STEALTH-TRODE CHILD DEFIB PADS
K911456 · LDD
Cardiotronics, Inc.
Cardiovascular · 196d
Cleared Oct 16, 1991
IVT GUIDING CATHETER
K911869 · DQY
Intensive Technology, Inc.
Cardiovascular · 173d