FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81745–81768 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 2000
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT,...
K001565 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 83d
Cleared Aug 10, 2000
MALLARD AIR OXYGEN ACCUBLENDER
K001609 · BZR
Mallard Medical, Inc.
Anesthesiology · 78d
Cleared Aug 10, 2000
PERMLASTIC 2
K001655 · ELW
Kerr Corp.
Dental · 71d
Cleared Aug 10, 2000
DC-TELL
K001799 · EBF
Austenal, Inc.
Dental · 57d
Cleared Aug 10, 2000
DC ZIRKON
K001815 · EIH
Austenal, Inc.
Dental · 56d
Cleared Aug 10, 2000
PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA
K001860 · IMC
Homedics, Inc.
Physical Medicine · 52d
Cleared Aug 10, 2000
CLEARFIL REPAIR
K001914 · KLE
Kuraray Company, Ltd.
Dental · 48d
Cleared Aug 10, 2000
PASCO MIC AND MIC/ID PANELS
K001953 · JWY
Pasco Laboratories, Inc.
Microbiology · 44d
Cleared Aug 10, 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · FPA
Abbott Laboratories
General Hospital · 38d
Cleared Aug 10, 2000
BIOTRACE, MODEL 1730
K002063 · MYU
Bryan Corp.
Neurology · 34d
Cleared Aug 10, 2000
INVACARE LIFT CHAIR
K002171 · INO
Invacare Corp.
Physical Medicine · 22d
Cleared Aug 10, 2000
POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)
K002190 · GAM
Cp Medical
General & Plastic Surgery · 21d
Cleared Aug 10, 2000
CARONY
K002205 · IOR
Bruno Independent Living Aids, Inc.
Physical Medicine · 20d
Cleared Aug 10, 2000
ELECSYS CA 15-3 CALCHECK
K002353 · JIS
Roche Diagnostics Corp.
Immunology · 8d
Cleared Aug 10, 2000
PROTEMP H
K002364 · EBG
Espe Dental AG
Dental · 7d
Cleared Aug 10, 2000
SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)
K994231 · ODA
Siemens Medical Corp.
Gastroenterology & Urology · 238d
Cleared Aug 09, 2000
IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
K000574 · EGJ
Wr Medical Electronics Co.
Physical Medicine · 169d
Cleared Aug 09, 2000
GOLDFINGER DEVICE
K001162 · FMK
Mali-Tech , Ltd.
General & Plastic Surgery · 121d
Cleared Aug 09, 2000
KWIKKMODEL
K001414 · ELW
R-Dental Dentalerzeugnisse GmbH
Dental · 97d
Cleared Aug 09, 2000
QUINTON Q-STRESS, MODEL 000483
K001492 · DPS
Quinton, Inc.
Cardiovascular · 89d
Cleared Aug 09, 2000
MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
K001727 · BSZ
Blease Medical Equipment , Ltd.
Anesthesiology · 64d
Cleared Aug 09, 2000
HOTLINE 2 FLUID WARMER
K001764 · LGZ
Sims Level 1, Inc.
General Hospital · 58d
Cleared Aug 09, 2000
MODIFICATION TO PASCO MIC AND MIC/ID PANELS
K001887 · JWY
Pasco Laboratories, Inc.
Microbiology · 49d
Cleared Aug 09, 2000
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K002012 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 37d