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
122161–122184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1991
MINICLINIC OVULATION PREDICTION TEST
K910351 · CEP
Vanguard Biomedical Corp.
Chemistry · 65d
Cleared Mar 21, 1991
FLOSCOPE MICRODOP
K910441 · DPT
Advance Medical Device, Inc.
Cardiovascular · 49d
Cleared Mar 21, 1991
STERILE DISPOSABLE DRAPE(S)
K910468 · FZI
E.M. Adams
General & Plastic Surgery · 45d
Cleared Mar 21, 1991
MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS
K910523 · FRN
Baxter Healthcare Corp
General Hospital · 44d
Cleared Mar 21, 1991
U.S. MEDICAL PS-1000 PEDIATRIC SCALE
K910581 · FRW
U.S. Medical Corp.
General Hospital · 38d
Cleared Mar 21, 1991
U.S. MEDICAL PS-2000 PEDIATRIC SCALE
K910582 · FRW
U.S. Medical Corp.
General Hospital · 38d
Cleared Mar 21, 1991
U.S. MEDICAL PS-3000 NEONATAL SCALE
K910583 · FRW
U.S. Medical Corp.
General Hospital · 38d
Cleared Mar 21, 1991
CEDIA(R) DIGOXIN SC ASSAY
K910642 · KXT
Microgenics Corp.
Toxicology · 36d
Cleared Mar 21, 1991
AUTO SASH (TM)
K910695 · FPA
Block Medical, Inc.
General Hospital · 30d
Cleared Mar 21, 1991
FLYNN TISSUE PROBE AND BLUNT DISSECTOR
K910713 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 29d
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