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
138457–138480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 1987
ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM
K872390 · JHI
Nichols Institute Diagnostics
Chemistry · 75d
Cleared Sep 02, 1987
PARAMAX URINE/CSF CALIBRATOR
K872789 · JIX
American Dade
Chemistry · 50d
Cleared Sep 02, 1987
CYBERFLUOR 615 IMMUNOANALYZER
K872803 · KHO
Cyberfluor, Inc.
Chemistry · 49d
Cleared Sep 02, 1987
ACROMED SCREW DRIVER
K873066 · HXX
Buckman Co., Inc.
Orthopedic · 28d
Cleared Sep 02, 1987
ACROMED BONE SCREW TAP SLEEVES
K873067 · HWX
Buckman Co., Inc.
Orthopedic · 28d
Cleared Sep 02, 1987
MULTI ANALYTE MIXTURES, CALIBRATORS
K873116 · JIX
Biotrol, USA, Inc.
Chemistry · 23d
Cleared Sep 02, 1987
BIOTROL REFERENCE
K873118 · JIX
Biotrol, USA, Inc.
Chemistry · 23d
Cleared Sep 02, 1987
BIOTROL MAGNESIUM CALMAGITE
K873180 · JGJ
Biotrol, USA, Inc.
Chemistry · 21d
Cleared Sep 02, 1987
ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT
K873310 · CGX
Abbott Laboratories
Chemistry · 15d
Cleared Sep 01, 1987
CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100
K870804 · DTR
American Bentley
Cardiovascular · 186d
Cleared Sep 01, 1987
MICRO MAMMO I MAMMOGRAPHY UNIT
K871048 · IZH
Amerasia Import-Export, Inc.
Radiology · 168d
Cleared Sep 01, 1987
HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT
K871349 · JWH
Howmedica Corp.
Orthopedic · 148d
Cleared Sep 01, 1987
HOLTER ST SYSTEM, MODEL NO. 5000-20
K871389 · DSI
Holter Data Services
Cardiovascular · 147d
Cleared Sep 01, 1987
THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS
K872085 · LSW
Immunodiagnostics, Ltd.
Immunology · 92d
Cleared Sep 01, 1987
CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500
K872167 · DTP
American Bentley
Cardiovascular · 85d
Cleared Sep 01, 1987
ADJUSTABLE PEEP VALVE
K872202 · BYE
Med Air Technology, Inc.
Anesthesiology · 85d
Cleared Sep 01, 1987
DPS-4100 PLUS DIGITAL RADIOGRAPHY SYSTEM
K872455 · LLZ
Adac Laboratories
Radiology · 70d
Cleared Sep 01, 1987
BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT)
K872705 · GEI
Clinical Technology Corp.
General & Plastic Surgery · 56d
Cleared Sep 01, 1987
KARYOTEC 100
K872755 · LNJ
Amcor Electronics, Ltd.
Pathology · 50d
Cleared Sep 01, 1987
TECHMEDICA HEAVYD GAUGE TITANIUM MESH SHEET/STRIPS
K873005 · HRS
Techmedica, Inc.
Orthopedic · 28d
Cleared Aug 31, 1987
GENE-TRAK CAMPYLOBACTER ASSAY
K863270 · LQO
Integrated Genetics
Microbiology · 371d
Cleared Aug 31, 1987
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
K873117 · CGA
Biotrol, USA, Inc.
Chemistry · 21d
Cleared Aug 28, 1987
IQ DIGOXIN
K864223 · KXT
Bd Becton Dickinson Vacutainer...
Toxicology · 304d
Cleared Aug 28, 1987
ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER
K864849 · JJE
Antek Instruments, Inc.
Chemistry · 261d