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

Filters: Cleared only ×
175,820 results
132529–132552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 1989
APEC GLUCOSE ANALYZER
K890524 · CGA
Amdev, Inc.
Chemistry · 41d
Cleared Mar 15, 1989
BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES
K890566 · CAE
Medi-Source, Inc.
Anesthesiology · 37d
Cleared Mar 15, 1989
EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
K890619 · GFO
Elite Diagnostic , Ltd.
Hematology · 36d
Cleared Mar 15, 1989
MEDILOG 9000-II AMBULATORY RECORDER
K890647 · DSH
Oxford Medilog, Inc.
Cardiovascular · 33d
Cleared Mar 15, 1989
ABUSCREEN FP FOR PHENCYCLIDINE
K890882 · LCL
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 15, 1989
ABUSCREEN FP BUFFER REAGENT
K890883 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 15, 1989
ABUSCREEN FP FOR MORPHINE
K890888 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 15, 1989
SYSTEM 3000 FLUIDIZED AIR BED
K890935 · IOQ
Dermanetics Corp.
Physical Medicine · 19d
Cleared Mar 14, 1989
BRYMASCAN-A
K881336 · IYO
Brymill Corp.
Radiology · 350d
Cleared Mar 14, 1989
NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER
K881865 · KGI
Norland Corp.
Radiology · 314d
Cleared Mar 14, 1989
FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY
K884047 · LYF
Disease Detection International, Inc.
Microbiology · 169d
Cleared Mar 14, 1989
CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER
K884552 · CAZ
Arrow Intl., Inc.
Anesthesiology · 134d
Cleared Mar 14, 1989
SURGICAL GLOVES
K884622 · KGO
Globe Ent., Inc.
General Hospital · 130d
Cleared Mar 14, 1989
VISTA MR 2055 HP SYSTEM
K885047 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 98d
Cleared Mar 14, 1989
NEEDLE STICK
K885122 · FMI
Poncy, Inc.
General Hospital · 95d
Cleared Mar 14, 1989
MEDSURG GREENE NEEDLE
K885145 · DWO
Medsurg Industries, Inc.
General & Plastic Surgery · 89d
Cleared Mar 14, 1989
MENTOR MDS
K885155 · IYN
Imex
Radiology · 89d
Cleared Mar 14, 1989
KODAK MULTILOADER 700
K885207 · IXW
Eastman Kodak Company
Radiology · 85d
Cleared Mar 14, 1989
ATTACHABLE LANZ (TENTATIVE)
K885216 · BSK
Mallinckroot, Inc.
Anesthesiology · 85d
Cleared Mar 14, 1989
RT6800 ECHOCARDIOGRAPHY SYSTEM
K885228 · IYO
General Electric Co.
Radiology · 84d
Cleared Mar 14, 1989
PERSONAL TRANSFER SYSTEM
K885270 · FNG
Columbus Mckinnon Corp.
General Hospital · 82d
Cleared Mar 14, 1989
GIARDIA STOOL ANTIGEN TEST KIT
K890003 · KHW
Lmd Laboratories
Microbiology · 70d
Cleared Mar 14, 1989
SINGLE PATIENT USE NASAL (CPAP) CIRCUIT
K890193 · BYG
Puritan Bennett Corp.
Anesthesiology · 55d
Cleared Mar 14, 1989
BAG DECANTER
K890272 · KPE
Superior Medical Products
General Hospital · 55d