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
122761–122784 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1991
450CM GUIDE WIRE FOR G.I. USE
K910722 · OCY
Terumo Corp.
Gastroenterology & Urology · 29d
Cleared Mar 21, 1991
TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH)
K910739 · DKZ
V-Tech, Inc.
Toxicology · 28d
Cleared Mar 21, 1991
FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR
K910747 · IOR
Fortress Litestyle
Physical Medicine · 28d
Cleared Mar 21, 1991
RECONSTITUTION DEVICE
K910793 · LHI
Baxter Healthcare Corp
General Hospital · 24d
Cleared Mar 21, 1991
LANDMARK VENOUS ACCESS DEVICE
K910799 · FOZ
Menlo Care, Inc.
General Hospital · 24d
Cleared Mar 21, 1991
DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID
K910809 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 23d
Cleared Mar 21, 1991
MCCONNELL SHOULDER BRACE
K910974 · IQI
Mcconnell Orthopedic
Physical Medicine · 14d
Cleared Mar 21, 1991
DAHLBERG MODEL LT BTE HEARING AID
K910979 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 14d
Cleared Mar 21, 1991
DAHLBERG MODEL LU BTE HEARING AID
K911063 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 10d
Cleared Mar 21, 1991
DAHLBERG MODEL LG BTE HEARING AID
K911064 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 10d
Cleared Mar 21, 1991
LATEX PATIENT EXAMINATION GLOVES
K911081 · LYY
Medical Device Inspection Co., Inc.
General Hospital · 10d
Cleared Mar 21, 1991
DAHLBERG MODEL LZ BTE HEARING AID
K911096 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 9d
Cleared Mar 20, 1991
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
K905614 · GBX
Baxter Healthcare Corp
General & Plastic Surgery · 96d
Cleared Mar 20, 1991
CYTOMEGALOVIRUS ANTIBODY SCREEN
K910003 · LJO
Immucor, Inc.
Microbiology · 77d
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