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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
94969–94992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1997
VERSA-CATH ARTERIAL CATHETER
K961883 · DXE
Ideas For Medicine, Inc.
Cardiovascular · 243d
Cleared Jan 13, 1997
STAT IM 5000 CASSETTE AUTOCLAVE
K962179 · FLE
Scican
General Hospital · 221d
Cleared Jan 13, 1997
MISTY OX TURBOHEATER
K962438 · CAF
Vital Signs, Inc.
Anesthesiology · 203d
Cleared Jan 13, 1997
FOUR-CHANNEL PREAMPLIFIER
K962455 · GWF
Cadwell Laboratories, Inc.
Neurology · 202d
Cleared Jan 13, 1997
TWO-CHANNEL PREAMPLIFIER
K962457 · GWF
Cadwell Laboratories, Inc.
Neurology · 202d
Cleared Jan 13, 1997
CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER
K962458 · GWF
Cadwell Laboratories, Inc.
Neurology · 202d
Cleared Jan 13, 1997
CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE
K962873 · OVQ
Vysis
Pathology · 174d
Cleared Jan 13, 1997
REP 3 QUTO-FLUR CHOLESTEROL-30
K962914 · JHO
Helena Laboratories
Chemistry · 171d
Cleared Jan 13, 1997
MAXI-TORQUE PLUS SOFTIP ANGIOGRAPHIC CATHETER
K963092 · DQO
Adam Spencer Corp.
Cardiovascular · 158d
Cleared Jan 13, 1997
11F GUIDING CATHETER
K963663 · DQY
Boston Scientific /International...
Cardiovascular · 122d
Cleared Jan 13, 1997
ASC HIGH PRESSURE BRAIDED TUBES
K964331 · DQO
Adam Spencer Corp.
Cardiovascular · 75d
Cleared Jan 13, 1997
AIA-PACK B12 ASSAY
K964348 · CDD
Tosoh Medics, Inc.
Chemistry · 74d
Cleared Jan 13, 1997
SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068)
K964403 · HGX
The First Years, Inc.
Obstetrics & Gynecology · 70d
Cleared Jan 13, 1997
ROCHE COBAS IBTEGRA REAGENT CASSETTES
K964457 · JQB
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared Jan 13, 1997
VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
K964587 · LEH
Bayer Corp.
Toxicology · 59d
Cleared Jan 13, 1997
SKYWAY
K964682 · IOR
Kid'S Wheel-Chairs
Physical Medicine · 52d
Cleared Jan 13, 1997
TAOS 28
K964940 · EJT
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
EL DORADO 40
K964941 · EJT
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
AURORA 52 (PM-01)
K964948 · EJT
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
AURORA 53
K964949 · EJT
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
LA PLATA 28 (PM-28)
K964950 · EJT
Gateway Alloys, Inc.
Dental · 34d
Cleared Jan 13, 1997
LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)
K965171 · JJY
Bio-Rad
Chemistry · 20d
Cleared Jan 10, 1997
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE...
K955384 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 415d
Cleared Jan 10, 1997
HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588
K960966 · FRF
Sunbeam-Oster Household Products
General Hospital · 305d