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
118273–118296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1992
GLUCOSE REAGENT SET
K914159 · CGA
Tech Intl. Co.
Chemistry · 132d
Cleared Jan 27, 1992
WHITESIDE ORTHOLOC MOD.TIBIAL AUGMENTATION COMP
K914169 · JWH
Dow Corning Wright
Orthopedic · 132d
Cleared Jan 27, 1992
PACEL(TM) FLOW DIRECTED PACING CATHETER
K914185 · LDF
Daig Corp.
Cardiovascular · 131d
Cleared Jan 27, 1992
CHIROFLEX II LENS MICROSERT(TM)
K914311 · HQL
Chiron Ophthalmics
Ophthalmic · 123d
Cleared Jan 27, 1992
DISPOSABLE VASCULAR ANGIOSCOPE
K914570 · LYK
Nobles-Lai
Cardiovascular · 104d
Cleared Jan 27, 1992
MP MINI PHOTOMETER
K914809 · JJX
Artel, Inc.
Chemistry · 94d
Cleared Jan 27, 1992
IL TEST(TM) BENZODIAZEPINE
K914815 · JXM
Instrumentation Laboratory CO
Chemistry · 94d
Cleared Jan 27, 1992
EVACUATION KIT #7-510-14
K914861 · GCJ
Northgate Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jan 27, 1992
OPTI-PLAST 5F PTA CATHETERS, MODIFICATION
K914976 · LIT
Vas-Cath, Inc.
Cardiovascular · 82d
Cleared Jan 27, 1992
ACU-GUARD
K915000 · GEX
Acuderm, Inc.
General & Plastic Surgery · 81d
Cleared Jan 27, 1992
PERMANENT PACING LEADS, MODIFICATION
K915007 · DTB
Oscor Medical Corp.
Cardiovascular · 84d
Cleared Jan 27, 1992
PERMANENT PACING PAD, MODIFICATION
K915008 · DTB
Oscor Medical Corp.
Cardiovascular · 84d
Cleared Jan 27, 1992
ATRAUMATIC TIP ANGIOGRAPHIC CATHETER
K915136 · DQO
Exonix Research Corp.
Cardiovascular · 75d
Cleared Jan 27, 1992
GESCO PER-Q-CATH CATHETER INTRODUCER
K915167 · DYB
Gesco Intl., Inc.
Cardiovascular · 73d
Cleared Jan 27, 1992
NOVA 5 NA/K/C1 ALALYZER
K915177 · CEM
Nova Biomedical Corp.
Chemistry · 73d
Cleared Jan 27, 1992
NOVA 11 NA/K/LI ANALYZER
K915178 · CEM
Nova Biomedical Corp.
Chemistry · 73d
Cleared Jan 27, 1992
LAPAROSCOPIC SNARE POUCH
K915360 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 80d
Cleared Jan 27, 1992
DIGITOXIN FPIA REAGENT SET
K915465 · LFM
Sigma Diagnostics, Inc.
Toxicology · 56d
Cleared Jan 27, 1992
SENSICARE SYNTHETIC MEDICAL GLOVES
K915478 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 52d
Cleared Jan 27, 1992
SYNERMED AST/GOT REAGENT KIT
K915555 · CIT
Synermed, Inc.
Chemistry · 47d
Cleared Jan 27, 1992
GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT
K915570 · CDZ
Incstar Corp.
Chemistry · 46d
Cleared Jan 27, 1992
KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION
K915701 · JHI
Eastman Kodak Company
Chemistry · 49d
Cleared Jan 27, 1992
CREATINE KINASE-MB (CK-MB) REAGENT SET
K915709 · CGS
Tech Intl. Co.
Chemistry · 59d
Cleared Jan 27, 1992
EMIT D.A.U. PHENCYCLIDINE ASSAY
K915728 · LCM
Syva Co.
Chemistry · 38d