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
160777–160800 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1982
PATIENT ISOLATOR #S-10/D-10
K820566 · FFT
Microelectrodes, Inc.
Gastroenterology & Urology · 21d
Cleared Mar 23, 1982
ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL
K820574 · BWN
David Simmonds Co., Inc.
General & Plastic Surgery · 21d
Cleared Mar 23, 1982
REPLACEMENT SAW BLADES FOR STRYKER AIR
K820601 · GFA
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 18d
Cleared Mar 23, 1982
OTE BIOMEDICA NEUROGRAPH 14
K820603 · GWQ
Del Mar Avionics
Neurology · 18d
Cleared Mar 23, 1982
OTE BIOMEDICA NEUROGRAPH 9
K820604 · GWQ
Del Mar Avionics
Neurology · 18d
Cleared Mar 23, 1982
OTE BIOMEDICA NEUROGRAPH 18
K820605 · GWQ
Del Mar Avionics
Neurology · 18d
Cleared Mar 23, 1982
MONAGHAN'S TRUE VOLUME EXERCISER
K820606 · BWF
Monaghan Medical Corp.
Anesthesiology · 18d
Cleared Mar 23, 1982
SYSTEM 10
K820678 · GZJ
Biostim, Inc.
Neurology · 12d
Cleared Mar 22, 1982
PHADEZYM ANALYZER
K813563 · JJQ
Pharmacia, Inc.
Chemistry · 90d
Cleared Mar 22, 1982
HS20 PORT. OPERATING ROOM MONITOR
K820399 · DRT
Medtel Pty. , Ltd.
Cardiovascular · 39d
Cleared Mar 19, 1982
E.W.L. P-TENS MODEL(TENS
K813601 · GZJ
Electronic Waveform Laboratory, Inc.
Neurology · 81d
Cleared Mar 19, 1982
UVEX ALPHA, BETA, GAMMA & DELTA SUN
K820016 · HQY
Bacou USA, Inc. and Uvex Safety, Inc.
Ophthalmic · 73d
Cleared Mar 19, 1982
ROOT CANAL FILLING RESIN
K820284 · KIF
Dentsply Intl.
Dental · 45d
Cleared Mar 19, 1982
CROWN & BRIDGE RESIN FOR FABRICAT/DE
K820456 · EBG
Rohm and Haas Co.
Dental · 28d
Cleared Mar 19, 1982
CHAMPION - HEARING AID
K820488 · ESD
Electrone, Inc.
Ear, Nose, Throat · 24d
Cleared Mar 19, 1982
ULTRAFINE TRAY ADHESIVE
K820489 · ELW
Buffalo Dental Mfg. Co., Inc.
Dental · 24d
Cleared Mar 19, 1982
SVENSK TK/2
K820503 · JEQ
Peter Martin Associates, Inc.
Dental · 22d
Cleared Mar 19, 1982
TYMPANOSTOMY TUBES (VARIOUS MODELS
K820510 · ETD
Abco Dist.
Ear, Nose, Throat · 24d
Cleared Mar 19, 1982
T-IV ELITE ALLOY
K820530 · EJS
Howmedica Corp.
Dental · 18d
Cleared Mar 19, 1982
POTATO DEXTROSE AGAR
K820550 · JSJ
American Laboratory Supply, Inc.
Microbiology · 17d
Cleared Mar 19, 1982
BRUCELLA AGAR W/15% SHEEP BLOOD
K820551 · JSG
American Laboratory Supply, Inc.
Microbiology · 17d
Cleared Mar 19, 1982
DERMATHPHYTE TEST MEDIUM
K820557 · JSJ
American Laboratory Supply, Inc.
Microbiology · 17d
Cleared Mar 19, 1982
ANAEROBE BLOOD AGAR
K820559 · JSG
American Laboratory Supply, Inc.
Microbiology · 17d
Cleared Mar 19, 1982
PHENYLETHANOL AGAR W/5% SHEEP BLOOD
K820560 · JSJ
American Laboratory Supply, Inc.
Microbiology · 17d