FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
88465–88488 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 1998
AIA-PACK TGAB ASSAY
K981522 · JZO
Tosoh Medics, Inc.
Immunology · 163d
Cleared Oct 08, 1998
RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R
K982436 · GZJ
Woodside Biomedical, Inc.
Neurology · 86d
Cleared Oct 08, 1998
EBI VUECATH ENDOSCOPIC SPINAL SYSTEM
K982484 · HRX
Electro-Biology, Inc.
Orthopedic · 83d
Cleared Oct 08, 1998
STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR
K982547 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 79d
Cleared Oct 08, 1998
TEMPBOND CLEAR-2
K982590 · EMA
Sybron Dental Specialties, Inc.
Dental · 76d
Cleared Oct 08, 1998
SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)
K982732 · HRS
Synthes
Orthopedic · 64d
Cleared Oct 08, 1998
BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K982820 · LLZ
Barco NV Display Systems
Radiology · 58d
Cleared Oct 08, 1998
PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64
K983222 · MOS
Medical Advances, Inc.
Radiology · 23d
Cleared Oct 07, 1998
HEALTH CHECK URI-TEST PROTEIN IN URINE
K972960 · JIR
Tcpi, Inc.
Chemistry · 422d
Cleared Oct 07, 1998
WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM
K974248 · HGM
Air-Shields, Inc.
Obstetrics & Gynecology · 329d
Cleared Oct 07, 1998
HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI...
K974854 · JHO
Morax
Chemistry · 282d
Cleared Oct 07, 1998
ZYMED TELEMETRY SYSTEM
K980186 · DSI
Agilent Technologies
Cardiovascular · 260d
Cleared Oct 07, 1998
ACCU-BITE HOME KIT DISCLUDER
K980953 · MQC
Jerome M. Simon
Dental · 208d
Cleared Oct 07, 1998
HYDRAGEL 6 CSF KIT
K981048 · CFF
Morax
Immunology · 201d
Cleared Oct 07, 1998
URISCREEN
K981084 · JXA
Diatech Diagnostics,Inc.
Microbiology · 196d
Cleared Oct 07, 1998
ODC B2 BIPOLAR CUP
K982389 · KWY
Ortho Development Corp.
Orthopedic · 90d
Cleared Oct 07, 1998
COBE VACUUM RELIEF CHECK VALVE
K982406 · MJJ
Cobe Cardiovascular, Inc.
Cardiovascular · 89d
Cleared Oct 07, 1998
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP
K982417 · GCJ
Innerdyne, Inc.
General & Plastic Surgery · 86d
Cleared Oct 07, 1998
CODA MPX30 MOTION ANALYSIS SYSTEM
K982425 · LXJ
Pinsco Inc. Dba B & L Engineering
Physical Medicine · 86d
Cleared Oct 07, 1998
QUANTA LITE CHROMATIN ELISA
K982603 · LLL
Inova Diagnostics, Inc.
Immunology · 72d
Cleared Oct 07, 1998
MEDIVISION HYSTEROSCOPE
K982659 · HIH
Medivision Scope Service Center, Inc.
Obstetrics & Gynecology · 69d
Cleared Oct 07, 1998
MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST
K982679 · DDR
Spectral Diagnostics, Inc.
Chemistry · 68d
Cleared Oct 06, 1998
SPO2 FINGER PROBES
K973970 · DQA
Medical Cables, Inc.
Anesthesiology · 354d
Cleared Oct 06, 1998
TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO
K980906 · MQS
Transonic Systems, Inc.
Gastroenterology & Urology · 210d