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
138961–138984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1987
COMPANION 50 REGULATOR/FLOWMETER
K872443 · DRT
Puritan Bennett Corp.
Cardiovascular · 28d
Cleared Jul 21, 1987
NOMAD (BASE UNIT/PORTABLE UNIT)
K872449 · BYJ
Minnesota Valley Engineering, Inc.
Anesthesiology · 28d
Cleared Jul 21, 1987
AN3500 WORTH DRAIN
K872457 · GBS
H.W. Andersen Products, Inc.
General & Plastic Surgery · 28d
Cleared Jul 21, 1987
AN3100 MULHOLLAND DRAIN
K872459 · GBS
H.W. Andersen Products, Inc.
General & Plastic Surgery · 28d
Cleared Jul 21, 1987
INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET
K872461 · DLJ
Innotron of Oregon, Inc.
Toxicology · 27d
Cleared Jul 21, 1987
INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET
K872462 · DLJ
Innotron of Oregon, Inc.
Toxicology · 29d
Cleared Jul 21, 1987
INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET
K872463 · DLJ
Innotron of Oregon, Inc.
Toxicology · 27d
Cleared Jul 21, 1987
CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS
K872511 · CHJ
Catachem, Inc.
Chemistry · 27d
Cleared Jul 21, 1987
1.1 COUPLERS AND 1.2 ADAPTERS
K872550 · HSZ
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 22d
Cleared Jul 21, 1987
ANTI-DNP MICROASSAY
K872560 · DHN
Diamedix Corp.
Immunology · 22d
Cleared Jul 21, 1987
TEMREX ETCHING GEL
K872569 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 22d
Cleared Jul 21, 1987
FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH
K872627 · CGJ
Serono Diagnostics, Inc.
Chemistry · 15d
Cleared Jul 21, 1987
INNOFLUOR VANCOMYCIN CALIBRATOR SET
K872644 · DLJ
Innotron of Oregon, Inc.
Toxicology · 15d
Cleared Jul 21, 1987
RGB CAMERA SYSTEM
K872661 · FWF
Aspen Laboratories, Inc.
General & Plastic Surgery · 14d
Cleared Jul 21, 1987
S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY
K872714 · GBI
Roseburg SA
General & Plastic Surgery · 11d
Cleared Jul 21, 1987
QM300 HAPTOGLOBIN ANTIBODY PACK
K872717 · DAD
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 11d
Cleared Jul 21, 1987
VINYL POLYSILOXANE IMPRESSION SYSTEM
K872745 · ELW
Crown Delta Corp.
Dental · 8d
Cleared Jul 21, 1987
VITALLIUM WIRE
K872746 · EJW
Austenal Dental, Inc.
Dental · 8d
Cleared Jul 20, 1987
ENZYGNOST ANTI-CMV IGG TEST
K863488 · GQI
Behring Diagnostics, Inc.
Microbiology · 314d
Cleared Jul 20, 1987
TDXR FETAL LUNG MATURITY
K871593 · JHG
Abbott Laboratories
Chemistry · 87d
Cleared Jul 17, 1987
FLEXIBLE FASCICULATED BONE PLATE
K870041 · JEY
The Deca Co.
Dental · 193d
Cleared Jul 17, 1987
CLEARFIL FII NEW BOND
K871634 · EBF
Kuraray Co.
Dental · 81d
Cleared Jul 17, 1987
CLEARFIL CORE NEW BOND
K871637 · EBF
Kuraray Co.
Dental · 81d
Cleared Jul 16, 1987
MINOS AUTOMATIC CELL COUNTER
K864579 · GKZ
Abx, Inc.
Hematology · 238d