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
126601–126624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 1990
RESPIRONICS' REMSTAR(TM) SLEEPEASY
K900113 · BYE
Respironics, Inc.
Anesthesiology · 78d
Cleared Mar 28, 1990
MODIFIED SEISMOCARDIOGRAPH
K900130 · DSB
Seismed Instruments, Inc.
Cardiovascular · 82d
Cleared Mar 28, 1990
ACUFEX STERILE CANNULATED INTERFERENCE SCREW
K900132 · HWC
Acufex Microsurgical, Inc.
Orthopedic · 77d
Cleared Mar 28, 1990
MASS SPECTROMETRY MONITORING LINES AND CONNECTORS
K900291 · CCK
F.L.W. Plastics, Inc.
Anesthesiology · 65d
Cleared Mar 28, 1990
HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES
K900339 · DTS
Shiley, Inc.
Cardiovascular · 64d
Cleared Mar 28, 1990
PROTEMP II
K900436 · EBG
Espe GmbH (Us)
Dental · 57d
Cleared Mar 28, 1990
SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY
K900601 · KFM
3M Company
Cardiovascular · 48d
Cleared Mar 28, 1990
FLUORESCENT T12 UVA LAMP
K900649 · FTC
Light Sources, Inc.
General & Plastic Surgery · 47d
Cleared Mar 28, 1990
OXIMAX 100
K900843 · DQA
Pace Tech, Inc.
Anesthesiology · 34d
Cleared Mar 28, 1990
ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM
K900989 · IZH
Fischer Imaging Corp.
Radiology · 26d
Cleared Mar 28, 1990
RADIOGRAPHIC GRID
K901012 · IXJ
Infab Corp.
Radiology · 23d
Cleared Mar 28, 1990
RADIOGRAPHIC FILM CASSETTE
K901013 · IXA
Infab Corp.
Radiology · 23d
Cleared Mar 28, 1990
FIBERLUME
K901108 · HBI
Burton
General & Plastic Surgery · 19d
Cleared Mar 28, 1990
CUFF BARO GUARD OR CBG ABBREVIATED
K901255 · BSK
Nelson Engineering, Inc.
Anesthesiology · 13d
Cleared Mar 28, 1990
CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY
K901279 · BTQ
Chatham Industries
Anesthesiology · 9d
Cleared Mar 27, 1990
DENTEC 4000
K894930 · ETN
Dentec, Inc.
Ear, Nose, Throat · 237d
Cleared Mar 27, 1990
PORTABLE AIR PLETHYSMOGRAPH
K895588 · DSB
Life Sciences Manufacturing, Inc.
Cardiovascular · 193d
Cleared Mar 27, 1990
BRACKMANN EMG MONITORING SYSTEM
K895838 · ETN
Wr Medical Electronics Co.
Ear, Nose, Throat · 176d
Cleared Mar 27, 1990
PORT-O-SCOPE(TM)
K895948 · EOQ
North American Medical Products, Inc.
Ear, Nose, Throat · 168d
Cleared Mar 27, 1990
MICROMATE 304
K896401 · EWO
Madsen North America, Inc.
Ear, Nose, Throat · 140d
Cleared Mar 27, 1990
PB PLUS LEAD LATEX GLOVES
K896759 · LZC
Sistem Med-Pro (M) Sdn Bhd
General Hospital · 116d
Cleared Mar 27, 1990
EPVC PATIENT EXAMINATION GLOVE
K896938 · LYZ
United Orient, Inc.
General Hospital · 104d
Cleared Mar 27, 1990
INTERFACE - CAVITY LINER
K897130 · EJK
Scientific Pharmaceuticals, Inc.
Dental · 90d
Cleared Mar 27, 1990
RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING
K897137 · DTL
Research Medical, Inc.
Cardiovascular · 90d