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
129529–129552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892787 · LYY
New World Projects, Inc.
General Hospital · 132d
Cleared Aug 21, 1989
HANDCARE PATIENT EXAMINATION GLOVES
K892948 · LYY
South Pacific Chemical Industries Sdn...
General Hospital · 131d
Cleared Aug 21, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892954 · LYY
Evermore Latex Products Co., Ltd.
General Hospital · 131d
Cleared Aug 21, 1989
LATEX EXAMINATION GLOVES
K893054 · LYY
Alfa Technologies, Inc.
General Hospital · 130d
Cleared Aug 21, 1989
LATEX EXAMINATION GLOVES
K893055 · LYY
Pro Brand Intl., Inc.
General Hospital · 130d
Cleared Aug 21, 1989
S,M,L LATEX EXAMINATION GLOVES
K893152 · LYY
Kc-Courser Ent. Co., Ltd.
General Hospital · 129d
Cleared Aug 21, 1989
VINYL EXAMINATION GLOVES
K893368 · LYZ
Chuan Ming Plastic Industrial Co. , Ltd.
General Hospital · 118d
Cleared Aug 21, 1989
LATEX EXAMINATION GLOVES
K893372 · LYY
Oriental Medical Supplies, Inc.
General Hospital · 116d
Cleared Aug 21, 1989
AUDITORY TRAINER PE150R FM RECEIVER
K893431 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 111d
Cleared Aug 21, 1989
DEPUY CANNULATED BONE SCREW
K893512 · HWC
Depuy, Inc.
Orthopedic · 108d
Cleared Aug 21, 1989
DR. BOO LATEX EXAMINATION GLOVES
K893520 · LYY
Dynatech Medical Products
General Hospital · 105d
Cleared Aug 21, 1989
RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963
K893532 · CBN
Medipart Jerry Alexander
Anesthesiology · 105d
Cleared Aug 21, 1989
MECONIUM ASPIRATOR
K893649 · GCX
Gish Biomedical, Inc.
General Hospital · 98d
Cleared Aug 21, 1989
AEROSOL INHALATION MONITOR
K893665 · BWF
Vitalograph , Ltd.
Anesthesiology · 98d
Cleared Aug 21, 1989
SUCTION TIP
K893667 · JOL
Thomson & Shelton Instrumentation Co,...
General Hospital · 98d
Cleared Aug 21, 1989
EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405
K893692 · CIT
Diagnostic Systems
Chemistry · 97d
Cleared Aug 21, 1989
NOVA OXYGEN TENT
K893713 · BYL
Nova Health Systems, Inc.
Anesthesiology · 95d
Cleared Aug 21, 1989
KEYSTONE OXYGEN TENT
K893714 · BYL
Keystone Veterinary Supplies, Inc.
Anesthesiology · 95d
Cleared Aug 21, 1989
RUBAGEN
K893755 · LQN
Biokit USA, Inc.
Microbiology · 94d
Cleared Aug 21, 1989
ALBUMIN TEST (ALB) ITEM NUMBER: 65401
K893777 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 91d
Cleared Aug 21, 1989
FEVER LINE AND FEVER LINE PLUS
K893803 · KPD
Liquid Crystal Sciences, Inc.
General Hospital · 91d
Cleared Aug 21, 1989
SINGLE AND DUAL BAND DIPSTICK HCG TEST
K893873 · DHA
Ampcor, Inc.
Chemistry · 87d
Cleared Aug 21, 1989
MITEK STERILIZATION TRAY
K893886 · FLE
Mitek Surgical Products, Inc.
General Hospital · 83d
Cleared Aug 21, 1989
EMIT CONVENIENCE PACK: DIGOXIN ASSAY
K893910 · KXT
Syva Co.
Toxicology · 83d