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
159385–159408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 1982
MEDTRONIC ENERTRAX MODEL 7100
K822147 · DXY
Medtronic Vascular
Cardiovascular · 15d
Cleared Aug 06, 1982
NONINVASIVE TEMPORARY PACEMAKER
K822246 · DRO
Ross Research, Inc.
Cardiovascular · 8d
Cleared Aug 06, 1982
MODEL 8000 SECTOR IMAGER SYSTEM
K827286
Ote Biomedica
Radiology · 52d
Cleared Aug 06, 1982
MODEL 8100 SECTOR IMAGER
K827287
Ote Biomedica
Radiology · 52d
Cleared Aug 05, 1982
MONAGHAN'S PRESSURE ALARM
K821649 · CAP
Monaghan Medical Corp.
Anesthesiology · 62d
Cleared Aug 05, 1982
RESPIRACULT-STREP DEEP BED CULTURE PAD
K821659 · JSH
Orion Diagnostica, Inc.
Microbiology · 62d
Cleared Aug 05, 1982
SOLUTION ADMINISTRATION SET (W/O NEEDLE)
K821995 · FPA
Bertex Laboratories, Inc.
General Hospital · 29d
Cleared Aug 05, 1982
ACRO PACK
K822121 · JRL
Gelman Sciences, Inc.
Chemistry · 17d
Cleared Aug 05, 1982
ISOPROPANOL HEMOGLOBIN STABILITY TEST
K822123 · GKA
Helena Laboratories
Hematology · 17d
Cleared Aug 05, 1982
VOLU-SOL CARNOY FLUID
K822126 · IGM
Volu Sol Medical Industries
Pathology · 17d
Cleared Aug 05, 1982
VOLU-SOL ZENKERS FIXATIVE
K822127 · IFH
Volu Sol Medical Industries
Pathology · 17d
Cleared Aug 05, 1982
VOLU-SOL SINGLE DIFFERENTIAL STAIN
K822128 · ICN
Volu Sol Medical Industries
Pathology · 17d
Cleared Aug 05, 1982
VOLU-SOL BOVINS FIXATIVE
K822129 · IGN
Volu Sol Medical Industries
Pathology · 17d
Cleared Aug 05, 1982
DADE CHILL TRAY
K822132 · JRR
American Dade
Chemistry · 16d
Cleared Aug 05, 1982
IMMUCHEM COVALENT-COAT
K822140 · JKC
Immuchem Corp.
Chemistry · 16d
Cleared Aug 05, 1982
CORNING 101 PRINTER
K822146 · JQP
Corning Medical & Scientific
Chemistry · 15d
Cleared Aug 05, 1982
UREA NITROGEN (ENZYMATIC) DETERMINATION
K822154 · CDN
The Dow Chemical Co.
Chemistry · 13d
Cleared Aug 05, 1982
2XC MICROSCOPE
K822207 · IBJ
Amarel Precision Instruments, Inc.
Pathology · 13d
Cleared Aug 04, 1982
IMPROVED GONO GEN
K821362 · LIC
New Horizons Diagnostics Co.
Microbiology · 89d
Cleared Aug 03, 1982
BIOBRANE R II BRAND
K820620 · FRO
Woodroof Mfg., Inc.
General & Plastic Surgery · 148d
Cleared Aug 03, 1982
CRITIKON #817 ESOPHAGEAL MULTI-PROBE
K821890 · BZT
Critikon Company, LLC
Anesthesiology · 39d
Cleared Aug 03, 1982
STARKEY MODEL HAL-1
K821908 · ETW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 36d
Cleared Aug 03, 1982
MENTOR POTENTIAL ACUITY METER
K821932 · HOX
Mentor O & O, Inc.
Ophthalmic · 35d
Cleared Aug 03, 1982
CHLAMYDELISA TEST KIT
K821967 · LJC
M.A. Bioproducts
Microbiology · 32d