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
127057–127080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 1990
QUANTUM QAD-1E ANGIODYNOGRAPH ULTRASOUND SYSTEM
K895147 · IYO
Quantum Intl.
Radiology · 185d
Cleared Feb 23, 1990
HYPEX
K895274 · BYW
Global Business, Inc.
Anesthesiology · 184d
Cleared Feb 23, 1990
SXT-60F/60M MOBILE C ARM X-RAY UNIT
K896387 · OXO
Toshiba America Medical Systems, In.C
Radiology · 109d
Cleared Feb 23, 1990
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC
K896744 · JXM
Bio-Rad
Toxicology · 85d
Cleared Feb 23, 1990
CARBON DIOXIDE REAGENT
K896812 · KHS
Pointe Scientific, Inc.,
Chemistry · 81d
Cleared Feb 23, 1990
TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD)
K896829 · JGT
Technicon Instruments Corp.
Chemistry · 81d
Cleared Feb 23, 1990
MODEL BT-1 FOT BOLT INSTALLATION KIT
K896834 · GWM
Pearl Instruments Corp.
Neurology · 80d
Cleared Feb 23, 1990
THYROID STIMULATING HORMONE-EIA-XT
K896867 · JLW
In Vitro Diagnostics, Inc.
Chemistry · 79d
Cleared Feb 23, 1990
ALPHA-STIM CS
K896948 · GZJ
Electromedical Products, Inc.
Neurology · 72d
Cleared Feb 23, 1990
ABBOTT SPECTRUM URIC ACID REAGENT KIT
K896954 · KNK
Abbott Laboratories
Chemistry · 71d
Cleared Feb 23, 1990
SIEMENS ENDO-P-PROBE
K897098 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 64d
Cleared Feb 23, 1990
COULTER AST (GOT) REAGENT
K897165 · CIT
Coulter Electronics, Inc.
Chemistry · 57d
Cleared Feb 23, 1990
COULTER TOTAL PROTEIN REAGENT
K897166 · CEK
Coulter Electronics, Inc.
Chemistry · 57d
Cleared Feb 23, 1990
QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT
K897169 · CDT
Photec Diagnostics, Inc.
Chemistry · 57d
Cleared Feb 23, 1990
BIOTRACK IMMUNOCHEMISTRY MONITOR
K900372 · JJQ
Biotrack, Inc.
Toxicology · 28d
Cleared Feb 23, 1990
MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
K900498 · LZG
Cardiac Pacemakers, Inc.
General Hospital · 36d
Cleared Feb 23, 1990
MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE
K900586 · LLZ
Medrad, Inc.
Radiology · 16d
Cleared Feb 23, 1990
SERATEST ENA [SSA] KIT
K900617 · LLL
Hemagen Diagnostics, Inc.
Immunology · 15d
Cleared Feb 22, 1990
SPATULA FOR PAP SMEAR COLLECTION
K893229 · HHT
Medical Device Inspection Co., Inc.
Obstetrics & Gynecology · 300d
Cleared Feb 22, 1990
TYPE EXPIRED CO2 9270, CAPNOGRAPH
K895001 · CCK
S & W Medico Teknik
Anesthesiology · 203d
Cleared Feb 22, 1990
STERILE SURGEON'S GLOVES (C T R GLOVES)
K895230 · KGO
Tan D. W. Trading Co., Inc.
General Hospital · 191d
Cleared Feb 22, 1990
DEN-MAT LAMI-QUICK
K895269 · ELL
Den-Mat Corp.
Dental · 183d
Cleared Feb 22, 1990
STEAM STERILIZER (AUTOCLAVE), DENTAL
K895638 · FLE
Porter Instrument Co., Inc.
General Hospital · 156d
Cleared Feb 22, 1990
ACCU-BEAM WAVEGUIDE
K895656 · GEX
Tti Medical
General & Plastic Surgery · 156d