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
94201–94224 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1997
SATURNE MULTILEAF COLLIMATOR
K970303 · IXI
General Electric Co.
Radiology · 88d
Cleared Apr 25, 1997
MODIFIED E-PACK PROCEDURE KIT
K970317 · GAM
Ethicon, Inc.
General & Plastic Surgery · 88d
Cleared Apr 25, 1997
NATURE'S CRADLE
K970334 · FMS
Infant Advantage, Inc.
General Hospital · 87d
Cleared Apr 25, 1997
F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM
K970380 · FMI
Pyng Medical Corp.
General Hospital · 81d
Cleared Apr 25, 1997
UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
K970593 · GJT
Universal Reagents, Inc.
Hematology · 66d
Cleared Apr 25, 1997
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
K970607 · GJT
Universal Reagents, Inc.
Hematology · 66d
Cleared Apr 25, 1997
ETEST SPARFLOXACIN
K970820 · JWY
Ab Biodisk
Microbiology · 50d
Cleared Apr 25, 1997
ACCULINE PREGNANCY TEST
K971122 · JHI
Genix Biotek, Inc.
Chemistry · 29d
Cleared Apr 24, 1997
SAFE-CATH
K960764 · FOZ
Scientific Device Manufacturer, LLC
General Hospital · 423d
Cleared Apr 24, 1997
SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM
K962882 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 274d
Cleared Apr 24, 1997
IMMULITE TOXOPLASMA QUANTITATIVE IGG
K962936 · LGD
Diagnostic Products Corp.
Microbiology · 269d
Cleared Apr 24, 1997
EVS
K963886 · DYB
Applied Medical Resources
Cardiovascular · 210d
Cleared Apr 24, 1997
P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE
K963989 · ITX
Cardiovascular Dynamics, Inc.
Radiology · 202d
Cleared Apr 24, 1997
FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS
K963991 · GEX
Full Spectrum, Inc.
General & Plastic Surgery · 202d
Cleared Apr 24, 1997
(FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI...
K963996 · GEX
Full Spectrum, Inc.
General & Plastic Surgery · 202d
Cleared Apr 24, 1997
VANTAGE PERIPHERAL DILATATION CATHETER
K965183 · LIT
Guidant Corp.
Cardiovascular · 121d
Cleared Apr 24, 1997
CLINICAL DIAGNOSTIC SOFTWARE
K970288 · KPS
Nuccardiac Software, Inc.
Radiology · 90d
Cleared Apr 24, 1997
ACCESSORIES TO THE STEREOTACTIC BODY FRAM
K970291 · IYE
Elekta Instrument AB
Radiology · 90d
Cleared Apr 24, 1997
JUPITER PTA CATHETERS (VARIOUS)
K970299 · LIT
Cordis Corp.
Cardiovascular · 87d
Cleared Apr 24, 1997
CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
K970392 · DRE
Cordis Corp.
Cardiovascular · 80d
Cleared Apr 24, 1997
UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)
K970519 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 72d
Cleared Apr 24, 1997
ACUPUNCTURE NEEDLES
K970574 · MQX
C.A.I. Industries Corp.
General Hospital · 70d
Cleared Apr 24, 1997
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
K970697 · JDI
Osteonics Corp.
Orthopedic · 58d
Cleared Apr 24, 1997
PYR SWAB
K970832 · JTO
Remel, Inc.
Microbiology · 48d