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
128473–128496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1989
HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE
K895868 · GYK
Baxter Healthcare Corp
Neurology · 27d
Cleared Oct 31, 1989
DETECTADOT SYSTEM 2000 HETEROPHILE TEST
K895891 · KTN
Gull Laboratories, Inc.
Immunology · 26d
Cleared Oct 31, 1989
MODEL FEL5100 FLOOR LIGHT
K895950 · FSS
F.W. Lang Co.
General & Plastic Surgery · 21d
Cleared Oct 30, 1989
E-RAM
K884126 · DSH
Reynolds Medical , Ltd.
Cardiovascular · 395d
Cleared Oct 30, 1989
1100 VITAL SIGNS MONITOR
K884643 · DSI
Criticare Systems, Inc.
Cardiovascular · 357d
Cleared Oct 30, 1989
SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES
K892323 · DSB
Seismed Instruments, Inc.
Cardiovascular · 207d
Cleared Oct 30, 1989
TEVES ECM (ENDOTRACHEAL CARDIAC MONITOR)
K893609 · BTR
Leonides Y. Teves, M.D., P.A.
Anesthesiology · 173d
Cleared Oct 30, 1989
IMMUNODOT LYME TEST
K894410 · LSR
General Biometrics, Inc.
Microbiology · 105d
Cleared Oct 30, 1989
CIBA CORNING CERTAIN LYTE
K894576 · JJR
Ciba Corning Diagnostics Corp.
Chemistry · 101d
Cleared Oct 30, 1989
DART UREA NITROGEN
K894836 · CDQ
Coulter Electronics, Inc.
Chemistry · 91d
Cleared Oct 30, 1989
ANSWER DENTAL IMPLEMENTS, MIRROR
K894895 · EKJ
Tern Chien Ent. Co., Ltd.
Dental · 90d
Cleared Oct 30, 1989
ANSWER DENTAL IMPLEMENT, EXPLORER
K894896 · EKJ
Tern Chien Ent. Co., Ltd.
Dental · 90d
Cleared Oct 30, 1989
ANSWER DENTAL IMPLEMENT, FORCEPS
K894897 · EKJ
Tern Chien Ent. Co., Ltd.
Dental · 90d
Cleared Oct 30, 1989
990 GOLD
K894924 · EJT
Comprehensive Holistic Dentistry
Dental · 89d
Cleared Oct 30, 1989
AEROVENT
K894969 · BZA
Monaghan Medical Corp.
Anesthesiology · 84d
Cleared Oct 30, 1989
RESPITRACE PLUS
K894973 · FLS
Hogan & Hartson
Anesthesiology · 84d
Cleared Oct 30, 1989
PRESTO DIAGNOSTIC SPIROMETER
K894997 · BZG
Tamarac Systems Corp.
Anesthesiology · 83d
Cleared Oct 30, 1989
BAXTER BAFFLED TEE ADAPTER
K895014 · BZA
Baxter Healthcare Corp
Anesthesiology · 83d
Cleared Oct 30, 1989
MODIFIED INFANT NASAL CANNULAE ASSEMBLY
K895031 · BZD
Ackrad Laboratories
Anesthesiology · 83d
Cleared Oct 30, 1989
BIOPSY FORCEPS
K895098 · DWZ
Annex Medical, Inc.
Cardiovascular · 76d
Cleared Oct 30, 1989
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K895122 · LJC
Ciba Corning Diagnostics Corp.
Microbiology · 76d
Cleared Oct 30, 1989
VISTA MR 2055 HP SYSTEM
K895151 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 81d
Cleared Oct 30, 1989
TTS2800
K895161 · GZJ
Henley Intl.
Neurology · 69d
Cleared Oct 30, 1989
TTS2500
K895166 · GZJ
Henley Intl.
Neurology · 69d