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
122185–122208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 1991
KALTOSTAT WOUND DRESSING
K910059 · QSY
Calgon Vestal Div.
General & Plastic Surgery · 70d
Cleared Mar 20, 1991
KALTOSTAT WOUND PACKING
K910080 · QSY
Calgon Vestal Div.
General & Plastic Surgery · 70d
Cleared Mar 20, 1991
TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK
K910110 · FXX
3M Company
General Hospital · 69d
Cleared Mar 20, 1991
VACPAC PORTABLE ASPIRATION SYSTEM
K910271 · BTA
Jedmed Instrument Co.
General & Plastic Surgery · 56d
Cleared Mar 20, 1991
HPI SENSI-SHIELD GLOVE KIT
K910383 · KGO
Hpi, Inc.
General Hospital · 49d
Cleared Mar 19, 1991
NEURO N 50 LESION GENERATOR
K896450 · GXD
Leibinger & Fischer , Ltd.
Neurology · 495d
Cleared Mar 19, 1991
EEG-5400 SERIES
K902550 · GWQ
Nihon Kohden America, Inc.
Neurology · 286d
Cleared Mar 19, 1991
BCI-100 FECAL INCONTINENCE SYSTEM
K904646 · FAP
Biocare Intl.
Gastroenterology & Urology · 159d
Cleared Mar 19, 1991
MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION
K904904 · KGX
Graham-Field, Inc.
General & Plastic Surgery · 140d
Cleared Mar 19, 1991
HOT BIOPSY FORCEPS
K905088 · KGE
Esco Precision, Inc.
Gastroenterology & Urology · 125d
Cleared Mar 19, 1991
ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE
K905282 · GCT
Frantz Medical Development, Ltd.
Gastroenterology & Urology · 116d
Cleared Mar 19, 1991
CHEMTRAK ACCUMETER CHOLESTEROL TEST
K905405 · CHH
Chemtrak, Inc.
Chemistry · 106d
Cleared Mar 19, 1991
SURGICAL DRAPE
K910084 · KKX
Biocor Medical, Inc.
General Hospital · 70d
Cleared Mar 19, 1991
REDDICK IRRIGATION/ASPIRATION SYSTEM
K910117 · GAA
Ideal Medical, Inc.
General & Plastic Surgery · 67d
Cleared Mar 19, 1991
TARGET COCAINE METABOLITE-R
K910122 · KLN
V-Tech, Inc.
Immunology · 67d
Cleared Mar 19, 1991
TARGET COCAINE METABOLITE-V
K910123 · KLN
V-Tech, Inc.
Toxicology · 67d
Cleared Mar 19, 1991
CPI MODEL 2215/SEAMED MODEL 3400
K910223 · DTC
Seamed Corp.
Cardiovascular · 60d
Cleared Mar 19, 1991
PLATELET AGGREGATION REAGENTS
K910286 · GHR
Medical Diagnostic Technologies, Inc.
Hematology · 56d
Cleared Mar 19, 1991
FLEXIFLO SACKS-VINE GASTROSTOMY KITS
K910332 · KNT
Abbott Laboratories
Gastroenterology & Urology · 53d
Cleared Mar 19, 1991
ELASTIC ADHESIVE BANDAGE
K910436 · KGX
Byron Medical
General & Plastic Surgery · 47d
Cleared Mar 19, 1991
MODEL 3150-64 QUADRATURE SPINE COIL IN POSITIONER
K910513 · LNH
Medical Advances, Inc.
Radiology · 42d
Cleared Mar 19, 1991
MODEL 3150-21 QUADRATURE SPINE COIL IN POSITIONER
K910514 · LNH
Medical Advances, Inc.
Radiology · 42d
Cleared Mar 19, 1991
IPAZYME (TM) CHLAMYDIA IGG-IGA
K910644 · LKH
Savyon Diagnostics , Ltd.
Microbiology · 33d
Cleared Mar 19, 1991
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION
K910668 · LJC
Ortho Diagnostic Systems, Inc.
Microbiology · 34d