FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127417–127440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1990
MODIFIED AML + ACETABULAR CUP PROSTHESIS
K900891 · JDI
Depuy, Inc.
Orthopedic · 13d
Cleared Mar 09, 1990
PATIENT EXAMINATION GLOVES
K893606 · LZA
Aukland Mfg., Inc.
General Hospital · 303d
Cleared Mar 09, 1990
NICOLET BEAM II SYSTEM
K894629 · GWS
Nicolet Instrument Corp.
Neurology · 228d
Cleared Mar 09, 1990
MAGNETIC RESONANCE SYSTEM MODEL BMT-1100
K895328 · LNH
Bruker Medical Imaging, Inc.
Radiology · 190d
Cleared Mar 09, 1990
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM
K895479 · BYH
Thayer Medical Corp.
Anesthesiology · 179d
Cleared Mar 09, 1990
ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES
K895781 · LZC
Ansell Intl.
General Hospital · 163d
Cleared Mar 09, 1990
BIOPSY FORCEPS, (NON-RIGID)
K896146 · EOQ
Portlyn Corp.
Ear, Nose, Throat · 137d
Cleared Mar 09, 1990
AG-820PA FI02 MODULE
K896359 · CCL
Nihon Kohden America, Inc.
Anesthesiology · 123d
Cleared Mar 09, 1990
AIA-PACK T4
K896982 · KLI
Tosoh Corp.
Chemistry · 80d
Cleared Mar 09, 1990
PARI I.S.-2
K896984 · CAF
Dura Pharmaceuticals, Inc.
Anesthesiology · 88d
Cleared Mar 09, 1990
TOSOH AIA-PACK T3
K897001 · CDP
Tosoh Corp.
Chemistry · 81d
Cleared Mar 09, 1990
ROCHE STANDARDS FOR THE COBAS ISE MODULE
K897071 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 77d
Cleared Mar 09, 1990
AFFINITY(TM) HTSH(TM)
K897138 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 72d
Cleared Mar 09, 1990
COULTER TRIGLYCERIDES GPO REAGENT
K897159 · CDT
Coulter Electronics, Inc.
Chemistry · 71d
Cleared Mar 09, 1990
COULTER GLUCOSE REAGENT
K897160 · CFR
Coulter Electronics, Inc.
Chemistry · 71d
Cleared Mar 09, 1990
COULTER ALT (GPT) REAGENT
K897163 · CKA
Coulter Electronics, Inc.
Chemistry · 71d
Cleared Mar 09, 1990
COULTER LD (LDH-L) REAGENT
K897164 · CFJ
Coulter Electronics, Inc.
Chemistry · 71d
Cleared Mar 09, 1990
MILENIA (TM) DIGITOXIN
K900013 · LFM
Diagnostic Products Corp.
Toxicology · 66d
Cleared Mar 09, 1990
IMMUNOTECH HDL-CHOLESTEROL TEST
K900036 · LBS
Immunotech Corp.
Chemistry · 66d
Cleared Mar 09, 1990
VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM
K900064 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 64d
Cleared Mar 09, 1990
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
K900120 · LBR
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Mar 09, 1990
ABUSCREEN FP FOR METHAMPHETAMINE
K900143 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 57d
Cleared Mar 09, 1990
POWDER-FREE VINYL GLOVES
K900149 · LYZ
Good Glove Corp.
General Hospital · 57d
Cleared Mar 09, 1990
EZ-SCREEN:OPIATES
K900203 · DJG
Environmental Diagnostics, Inc.
Toxicology · 52d