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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
100177–100200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1995
PYRILINKS ASSAY KIT
K952506 · JMM
Metra Biosystems, Inc.
Chemistry · 156d
Cleared Nov 03, 1995
THE SWIRLER AEROSOL SYSTEM
K952893 · CAF
Amici, Inc.
Anesthesiology · 133d
Cleared Nov 03, 1995
FCP-9P, FIBER CHOLEDOCHOSCOPE
K953286 · FBN
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 113d
Cleared Nov 03, 1995
XENON CIRCUIT
K953513 · IYT
King Systems Corp.
Radiology · 100d
Cleared Nov 03, 1995
MICROSPIN 24
K953519 · GKF
Vulcon Technologies
Hematology · 99d
Cleared Nov 03, 1995
DEPUY STAINLESS STEEL SET SCREW
K953650 · HWC
Depuy, Inc.
Orthopedic · 91d
Cleared Nov 03, 1995
OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL
K954188 · GKZ
Immunotech Corp.
Hematology · 58d
Cleared Nov 03, 1995
STERILE FEEDING TUBE
K954218 · FPD
Baxter Healthcare Corp
Gastroenterology & Urology · 56d
Cleared Nov 03, 1995
NEXUS II FEMORAL COMPONENT
K954262 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 52d
Cleared Nov 03, 1995
INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
K954418 · CEW
Nichols Institute Diagnostics
Chemistry · 42d
Cleared Nov 03, 1995
ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI
K954571 · DIO
Princeton BioMeditech Corp.
Toxicology · 32d
Cleared Nov 03, 1995
KARL STORZ OPTICAL MEDIASTINOSCOPE
K954910 · EWY
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 9d
Cleared Nov 02, 1995
WITT BIOMEDICAL SERIES IV
K950436 · MHX
Witt Biomedical Corporation
Cardiovascular · 273d
Cleared Nov 02, 1995
SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS
K951247 · DTZ
Baxter Healthcare Corp
Cardiovascular · 227d
Cleared Nov 02, 1995
FREEDOM BATH
K952442 · ILJ
Grand Traverse Technologies
Physical Medicine · 161d
Cleared Nov 02, 1995
AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION
K953720 · KWQ
Aesculap, Inc.
Orthopedic · 85d
Cleared Nov 02, 1995
ENDOPATH OPEN OR ENDOSCOPIC ELECTROSUGICAL COAGULATION & CUTTING DEVICE
K954089 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 65d
Cleared Nov 02, 1995
APEX TUBING SET
K954440 · HRX
Linvatec Corp.
Orthopedic · 38d
Cleared Nov 02, 1995
FLEXZAN WOUND DRESSING
K954602 · MGP
Dow Hickam Pharmaceuticals, Inc.
General & Plastic Surgery · 36d
Cleared Nov 02, 1995
DERMAGRAN HYDROPHILIC WOUND DRESSING
K954738 · MGP
Derma Sciences, Inc.
General & Plastic Surgery · 17d
Cleared Nov 02, 1995
DERMAGRAN HYDROPHILIC OINTMENT
K954739 · FRO
Derma Sciences, Inc.
General & Plastic Surgery · 17d
Cleared Nov 02, 1995
DERMAGRAN WOUND DRESSING
K954740 · FRO
Derma Sciences, Inc.
General & Plastic Surgery · 17d
Cleared Nov 02, 1995
DERMAGRAN WET DRESSING (ZINC-SALINE)
K954742 · FRO
Derma Sciences, Inc.
General & Plastic Surgery · 17d
Cleared Nov 02, 1995
DERMAGRAN WOUND DRESSING CLEANER W/ZINC
K954743 · FRO
Derma Sciences, Inc.
General & Plastic Surgery · 17d