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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
163369–163392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1981
EMIT-CAD QUINIDINE ASSAY
K811460 · LBZ
Syva Co.
Toxicology · 14d
Cleared Jun 09, 1981
EMIT-AND METHOTREXATE CONTROL
K811461 · LAZ
Syva Co.
Toxicology · 14d
Cleared Jun 09, 1981
EMIT-CAD QUINDINE CONTROL
K811462 · LAS
Syva Co.
Toxicology · 14d
Cleared Jun 09, 1981
THERMODILUTION KIT
K811480 · KRB
American Pharmaseal Div. Ahsc
Cardiovascular · 13d
Cleared Jun 09, 1981
WAKO URIC ACID B TEST
K811504 · KNK
Wako Chemicals USA, Inc.
Chemistry · 13d
Cleared Jun 02, 1981
SUNLAMP
K803264 · FTC
Am Labs, Inc.
Radiology · 160d
Cleared Jun 02, 1981
FORMULATION CHANGE IN UNITED SKIN BARR
K810726 · EXB
Howmedica Corp.
Gastroenterology & Urology · 77d
Cleared Jun 02, 1981
ADULT & PEDIATRIC TRACHEOSTOMY MASKS
K810946 · BYF
Airlife, Inc.
Anesthesiology · 56d
Cleared Jun 02, 1981
AIR ENTRAINMENT TRACH T
K810947 · BYF
Airlife, Inc.
Anesthesiology · 56d
Cleared Jun 02, 1981
ARROW NEEDLE-CATHETER JEJUNOSTOMY KIT
K810979 · KNT
Arrow Intl., Inc.
Gastroenterology & Urology · 53d
Cleared Jun 02, 1981
SOLUTION ADMINISTRATION SET
K811006 · FPA
Suru Chemicals & Pharmaceuticals, Ltd.
General Hospital · 49d
Cleared Jun 02, 1981
RESPIRATORY SENSOR
K811014 · BZQ
Impact Instrumentation, Inc.
Anesthesiology · 48d
Cleared Jun 02, 1981
SUNLAMP
K811029 · FTC
Williams & Connolly
Radiology · 47d
Cleared Jun 02, 1981
KRYPTON MASKS & TUBING
K811118 · IYT
Medi-Physics Inc. Dba Nycomed...
Radiology · 39d
Cleared Jun 02, 1981
SUR-FIT IRRIGATION SLEEVE
K811160 · EXD
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 35d
Cleared Jun 02, 1981
SURGICAL DRESSING SET
K811166
Washington-Greene County Branch...
General & Plastic Surgery · 35d
Cleared Jun 02, 1981
N-D0-SURE
K811185 · CBH
Ackrad Laboratories
Anesthesiology · 34d
Cleared Jun 02, 1981
VAC-RITE SUNCTION COLLECTION
K811192 · KDQ
Bd Becton Dickinson Vacutainer...
General Hospital · 33d
Cleared Jun 02, 1981
MINISTIM
K811224 · GZJ
Medical Design & Manufacturing Corp.
Neurology · 29d
Cleared Jun 02, 1981
MODEL 560 SERIES VOLUMETRIC INFUSION
K811238 · FRN
Y
General Hospital · 29d
Cleared Jun 02, 1981
RESPIRATORY SENSOR (MODEL 409 W/NASOPH.)
K811265 · BZQ
Impact Instrumentation, Inc.
Anesthesiology · 21d
Cleared Jun 02, 1981
EXTENDED TUMOR CALIPER
K811278 · FTY
Mick Radio-Nuclear Instruments, Inc.
General & Plastic Surgery · 25d
Cleared Jun 02, 1981
FLEX-TEMPLATE
K811280 · KDC
Mick Radio-Nuclear Instruments, Inc.
General & Plastic Surgery · 25d
Cleared Jun 02, 1981
TEGADERM TRANSPARENT DRESSING
K811291 · KGX
3M Company
General & Plastic Surgery · 22d