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
136633–136656 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 1988
ABUSCREEN(R) EIA AMPHETAMINE
K874836 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 84d
Cleared Feb 16, 1988
RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)
K874863 · GQN
Monoclonal Antibodies, Inc.
Microbiology · 83d
Cleared Feb 16, 1988
DISPOSABLE SYRINGE
K875097 · FMF
California Ent.
General Hospital · 68d
Cleared Feb 16, 1988
TECHNICON SMAC 3 SYSTEM
K875105 · JJC
Technicon Instruments Corp.
Chemistry · 64d
Cleared Feb 16, 1988
60 ML RESERVOIR BAG, ITEM #200
K875155 · KPE
Prn Services, Inc.
General Hospital · 63d
Cleared Feb 16, 1988
IV EXTENSION SET
K875186 · FPK
Marquette Medical, Inc.
General Hospital · 56d
Cleared Feb 16, 1988
STERILE SURGICAL NATURAL LATEX GLOVES
K875349 · KGO
Marand Products, Inc.
General Hospital · 47d
Cleared Feb 16, 1988
HASTING FINGER FIXATOR INSTRUMENTS
K880046 · HXY
Buckman Co., Inc.
Orthopedic · 41d
Cleared Feb 16, 1988
JMS TRANSFUSION SET
K880174 · BRZ
Jms Co., Ltd.
General Hospital · 32d
Cleared Feb 16, 1988
MOBILIMB HAND C.P.M. UNIT
K880336 · JFA
Toronto Medical Corp.
Physical Medicine · 21d
Cleared Feb 16, 1988
MODIFIED AIR FLUIDIZED BED, KINAIR
K880340 · INX
Kinetic Concepts, Inc.
Physical Medicine · 21d
Cleared Feb 16, 1988
YUE/FA DISPOSABLE SYRINGE
K880350 · FMF
Honway International Co.
General Hospital · 21d
Cleared Feb 16, 1988
MODEL 938 BATHING SYSTEM
K880355 · ILJ
Ferno Ille-Forge
Physical Medicine · 21d
Cleared Feb 16, 1988
NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP
K880376 · GBS
Genesis Industries, Inc.
General & Plastic Surgery · 20d
Cleared Feb 16, 1988
TARGA (WHEELCHAIR)
K880423 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 15d
Cleared Feb 16, 1988
SCOOTA BUG (MOTORIZED VEHICLE)
K880424 · INI
A-Bec Mobility, Inc.
Physical Medicine · 15d
Cleared Feb 16, 1988
STERLING (MOTORIZED VEHICLE)
K880425 · INI
A-Bec Mobility, Inc.
Physical Medicine · 15d
Cleared Feb 12, 1988
BEAR NVM-1
K872660 · BZK
Bear Medical Systems, Inc.
Anesthesiology · 220d
Cleared Feb 12, 1988
TARGET PROGRAM & EPSON HX-20 COMPUTER
K872877 · HAW
Walter Lorenz Surgical, Inc.
Neurology · 206d
Cleared Feb 12, 1988
UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100
K872896 · CCE
American Bentley
Anesthesiology · 204d
Cleared Feb 12, 1988
AMICI KRYPTON ADMINISTRATION SYSTEM*
K872920 · IYT
Amici, Inc.
Radiology · 200d
Cleared Feb 12, 1988
PERMANENT MYOCARDIAL LEADS MP SERIES
K872971 · DTB
Oscor Medical Corp.
Cardiovascular · 198d
Cleared Feb 12, 1988
LUNG DIFFUSION GAS
K873586 · BXK
National Welders
Anesthesiology · 161d
Cleared Feb 12, 1988
THE PROTECTOR
K874412 · CAE
Tri Jon, Inc.
Anesthesiology · 107d