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
157033–157056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 1983
CRM-114 COLOR VIDEO CAMERA
K830924 · FET
Umi, Inc.
Gastroenterology & Urology · 27d
Cleared Apr 18, 1983
NYNEX II
K830932 · GZJ
La Jolla Technology, Inc.
Neurology · 26d
Cleared Apr 18, 1983
QUANTIMETRIX BROMERESOL PURPLE ALBUMIN
K830934 · CJW
Quantimetrix Corp.
Immunology · 26d
Cleared Apr 18, 1983
VASCULAR PRODUCTS IMPLANTABLE PACING
K830950 · DTB
Oscor, Inc.
Cardiovascular · 24d
Cleared Apr 18, 1983
FLOW-PAC TRIGLYCERIDE REAGENT
K830957
Amresco, Inc.
Chemistry · 24d
Cleared Apr 18, 1983
ENTERAL SOLUTION ADMIN. PUMP SET
K830965 · KNT
Corpak Co.
Gastroenterology & Urology · 21d
Cleared Apr 15, 1983
NOVA GAUZE
K830473 · NAB
American Threshold Industries, Inc.
General & Plastic Surgery · 59d
Cleared Apr 15, 1983
TRANSDUCER MODELS 450, 451, 452, 453, 454
K837229
Hoffrel Instruments, Inc.
Radiology · 45d
Cleared Apr 15, 1983
UNKNOWN
K837283
Tannhut
Radiology · 35d
Cleared Apr 14, 1983
INFANT CARE SYSTEM
K823899 · FMI
Narco Scientific
General Hospital · 108d
Cleared Apr 14, 1983
ELECTRONIC EXERCISE #313-PULSE RATE
K830282 · DRT
Walton Manufacturer Co.
Cardiovascular · 78d
Cleared Apr 14, 1983
PCA PUMP
K830452 · FRN
Abbott Laboratories
General Hospital · 58d
Cleared Apr 14, 1983
INFUSION PUMP #AS*6H
K830486 · FRN
Baxter Healthcare Corp
General Hospital · 58d
Cleared Apr 14, 1983
GRASE BY DYNAMICS MS 27 SYRINGE DRIVER
K830809 · FRN
Intermedics, Inc.
General Hospital · 31d
Cleared Apr 14, 1983
COMBISET OR INFUSION SET
K830868 · FPA
Pan-Tek Intl., Inc.
General Hospital · 27d
Cleared Apr 14, 1983
SPECIALTY SET MODEL IV7A01
K830891 · FPA
Valleylab, Inc.
General Hospital · 24d
Cleared Apr 14, 1983
SUCTION CATHETERS
K830942 · JOL
Medovations, Inc.
General Hospital · 21d
Cleared Apr 14, 1983
PERM. REPAIR KIT FOR LEONARD NORTON DUAL
K830969 · LJS
Norton Performance Plastics Corp.
General Hospital · 17d
Cleared Apr 13, 1983
THYMINE/THYMIDINE DISCS DDG
K830939 · JTO
Oxoid U.S.A., Inc.
Microbiology · 20d
Cleared Apr 13, 1983
ISOLATION MASK I.C.S.
K831062 · LGM
American Threshold Industries, Inc.
General Hospital · 5d
Cleared Apr 13, 1983
CEILEX LS-15/ALLMEC ARGOSTAT
K837352
Elscint, Inc.
Radiology · 9d
Cleared Apr 13, 1983
FLOATEX LS-22
K837353
Elscint, Inc.
Radiology · 9d
Cleared Apr 12, 1983
CHEMOTHERAPY INFUSION CATHETER
K822096 · JCY
American Heyer Schulte
General & Plastic Surgery · 270d
Cleared Apr 12, 1983
CONVERTORS PRIMARY WOUND DRESSING II
K822990 · FRO
American Hospital Supply Corp.
General & Plastic Surgery · 182d