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
135937–135960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1988
MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY
K880678 · DHA
Ventrex Laboratories, Inc.
Chemistry · 46d
Cleared Apr 05, 1988
ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT
K880743 · CIG
Abbott Laboratories
Chemistry · 41d
Cleared Apr 05, 1988
LDH-L REAGENT SET
K880842 · CFJ
Tech-Neal Scientific, Inc.
Chemistry · 39d
Cleared Apr 05, 1988
CREATININE REAGENT SET (KINETIC)
K880843 · CGX
Tech-Neal Scientific, Inc.
Chemistry · 39d
Cleared Apr 05, 1988
ALBUMIN REAGENT SET
K880844 · CIX
Tech-Neal Scientific, Inc.
Chemistry · 39d
Cleared Apr 05, 1988
CALCIUM REAGENT SET
K880845 · CIC
Tech-Neal Scientific, Inc.
Chemistry · 39d
Cleared Apr 05, 1988
SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
K880949 · CJY
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Apr 05, 1988
DISPOSABLE STERILE LATEX SURGICAL GLOVES
K881069 · KGO
Komin Trading Co.
General Hospital · 22d
Cleared Apr 05, 1988
UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR
K881156 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 18d
Cleared Apr 05, 1988
I.M.A. RETRACTOR
K881159 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 18d
Cleared Apr 05, 1988
STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01
K881254 · JQC
Norfolk Scientific, Inc.
Chemistry · 13d
Cleared Apr 05, 1988
XYLENE
K881282 · KEM
Anatech, Ltd.
Pathology · 11d
Cleared Apr 05, 1988
ANIMAL AND HUMAN SERA
K881287 · KIS
Cell Culture Laboratories
Pathology · 8d
Cleared Apr 04, 1988
NOVO VIVO MODEL #17140 AND #17135
K880377 · GAA
Genesis Industries, Inc.
General & Plastic Surgery · 68d
Cleared Apr 04, 1988
BOVINE CALF SERUM SUPPLEMENTED #A-2159
K880471 · KIS
Hyclone Laboratories, Inc.
Pathology · 61d
Cleared Apr 04, 1988
COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER
K880507 · GKZ
Coulter Electronics, Inc.
Hematology · 55d
Cleared Apr 04, 1988
MCT 8000 (MULTI-VISION CONTRAST TESTER)
K881059 · HOX
Vistech Consultants, Inc.
Ophthalmic · 24d
Cleared Apr 04, 1988
RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201
K881243 · LFX
Labsystems, Inc.
Microbiology · 14d
Cleared Apr 01, 1988
TEGASORB ULCER DRESSING #90-XXX
K872298 · FRO
3M Company
General & Plastic Surgery · 291d
Cleared Apr 01, 1988
BREATHGUARD APNEA MONITOR
K872833 · BZQ
Lada Intl., Inc.
Anesthesiology · 259d
Cleared Apr 01, 1988
FRAME, SPECTACLE
K873965 · HQZ
Swank Plus , Ltd.
Ophthalmic · 185d
Cleared Apr 01, 1988
GUIDE WIRE INTRODUCER
K873972 · DQX
Target Therapeutics
Cardiovascular · 185d
Cleared Apr 01, 1988
CIRCADIAN STRESS TEST II
K874641 · DPS
Circadian, Inc.
Cardiovascular · 140d
Cleared Apr 01, 1988
SITE SOLUTION ADMINISTRATION SET
K874725 · FPA
Site Microsurgical Systems, Inc.
General Hospital · 135d