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
154249–154272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1984
MODIF. OF EMIT URINE BENZODIAZEPINE
K833578 · JXM
Syva Co.
Toxicology · 106d
Cleared Jan 26, 1984
MODIF. OF EMIT URINE AMPHETAMINE
K833579 · DKZ
Syva Co.
Toxicology · 106d
Cleared Jan 26, 1984
MODIF. OF EMIT URINE CANNABINOID
K833580 · LDJ
Syva Co.
Toxicology · 106d
Cleared Jan 26, 1984
MODIF. OF EMIT URINE OPIATE ASSAY
K833581 · DJG
Syva Co.
Toxicology · 106d
Cleared Jan 26, 1984
P.T.I. DRESSING CHANGE TRAYS
K833758 · FMC
Packaging Technologies, Inc.
General Hospital · 92d
Cleared Jan 25, 1984
PMT-OPTICA LINE
K831118 · KDC
Pmt, Inc.
General & Plastic Surgery · 295d
Cleared Jan 25, 1984
SELECTRODE SYSTEM
K832634 · BWK
Bio-Stimu Trend Corp.
Neurology · 174d
Cleared Jan 25, 1984
BURLINGTON STERILE ANTIMICROBIAL STOCK
K833121 · KKX
Balfour, Inc.
General Hospital · 134d
Cleared Jan 25, 1984
BURLINGTON ANTIMICROBIAL STOCKINEETTE
K833122 · KKX
Balfour, Inc.
General Hospital · 134d
Cleared Jan 25, 1984
SKIN TECH. SURGI-STRIPS
K833258 · FPX
Lee Tec Corp.
General & Plastic Surgery · 127d
Cleared Jan 25, 1984
ACCURATE MEASUREMENT DEVICE KG-AMD
K833674 · GCX
Sorensen Research
General Hospital · 99d
Cleared Jan 25, 1984
AMER. V. MUELLER SURG. STAPLES ILA
K833698 · GDW
American Heyer Schulte
General & Plastic Surgery · 71d
Cleared Jan 25, 1984
PREPACELL THIN NEEDLE ASPIRATION TRAY
K833719 · KOD
Applied Medical Devices, Inc.
Gastroenterology & Urology · 93d
Cleared Jan 25, 1984
SINGLE-USE SURGICAL DRAPES
K833877 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 78d
Cleared Jan 25, 1984
STERILE SOLUTION WARMER
K833944 · LHC
National Fabtronix, Inc.
General Hospital · 71d
Cleared Jan 25, 1984
PUMP INFUSION WEARABLE INFUSION PUMP
K833966 · JSJ
Oximetrix, Inc.
Microbiology · 70d
Cleared Jan 25, 1984
LYMPHANGIOGRAPHY SET SPECIAL 30G
K834071 · FPA
Hyperion, Inc.
General Hospital · 61d
Cleared Jan 25, 1984
FLO-GARD 8000 COMPUTER CONTROL INFUSI
K834154 · LDR
Travenol Laboratories, S.A.
General Hospital · 54d
Cleared Jan 25, 1984
DOPPLER PHANTOM FLOW CONTROL SYS
K834481 · IXF
Radiation Measurements, Inc.
Radiology · 41d
Cleared Jan 25, 1984
TISSUE MIMICKING ULTRASOUND PHANTOMS
K834482 · IXF
Radiation Measurements, Inc.
Radiology · 41d
Cleared Jan 25, 1984
STERILE WET DRESSING PACK
K834532 · KDD
W.G. Whitney Corp.
General & Plastic Surgery · 35d
Cleared Jan 25, 1984
CRYSTALCONE FACE MASK-MED-W/HOOKRING
K834536 · BSJ
Warne Surgical Products, Ltd.
Anesthesiology · 34d
Cleared Jan 24, 1984
LABORATORY DATA MGMT SYSTEM SDMS
K831838 · JQP
Vickers America Medical Corp.
Chemistry · 231d
Cleared Jan 24, 1984
STAR HCG MONOCLONAL ANTIBODY IMMUNORAD
K832796 · JHI
Syncor Intl. Corp.
Chemistry · 159d