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
94393–94416 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1997
IMMULITE THYROID AUTOANTIBODY CONTROL MODULE
K971051 · JJX
Diagnostic Products Corp.
Immunology · 17d
Cleared Apr 09, 1997
POINT-OF-CARE BLOOD GAS MONITOR SYSTEM
K961790 · CCC
Optical Sensors, Inc.
Anesthesiology · 335d
Cleared Apr 09, 1997
VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW...
K962700 · DPT
Vasamedics, LLC
Cardiovascular · 271d
Cleared Apr 09, 1997
PAP BRUSH
K963801 · HHT
Young OU Brush Co.
Obstetrics & Gynecology · 198d
Cleared Apr 09, 1997
EBI SPINELINK SYSTEM
K964533 · MNH
Electro-Biology, Inc.
Orthopedic · 148d
Cleared Apr 09, 1997
OTOSILK OTOLOGICAL GRAFT DRESSING
K964534 · NAD
Boston Medical Products, Inc.
General & Plastic Surgery · 148d
Cleared Apr 09, 1997
RELIANCE PF FEMORAL STEMS
K970200 · LZO
Howmedica Corp.
Orthopedic · 78d
Cleared Apr 09, 1997
INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
K970492 · LKF
Ackrad Laboratories
Obstetrics & Gynecology · 58d
Cleared Apr 09, 1997
SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615)
K970576 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 55d
Cleared Apr 09, 1997
3M RED DOT 2560 & 2570 MONITORING ELECTRODES
K970796 · DRX
3M Healthcare
Cardiovascular · 36d
Cleared Apr 09, 1997
MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
K970965 · ERL
Midas Rex Pneumatic Tools, Inc.
Ear, Nose, Throat · 23d
Cleared Apr 09, 1997
FEMTEX 100% COTTON TAMPONS
K971228 · HEB
Regu-Tech Assoc., Inc.
Obstetrics & Gynecology · 78d
Cleared Apr 08, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT
K962208 · CGR
Nichols Institute Diagnostics
Chemistry · 302d
Cleared Apr 08, 1997
SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
K963755 · CBP
Spiracle Technology
Anesthesiology · 202d
Cleared Apr 08, 1997
IMMULITE COCAINE METABOLITE
K963918 · DIO
Diagnostic Products Corp.
Toxicology · 190d
Cleared Apr 08, 1997
MINIMED INSULIN PUMP, MODEL 505
K963948 · LZG
Medtronic Minimed
General Hospital · 188d
Cleared Apr 08, 1997
MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
K964787 · LLL
Mardx Diagnostics, Inc.
Immunology · 130d
Cleared Apr 08, 1997
VIDAS C. DIFFICILE TOXIN A II ASSAY
K964887 · LLH
Biomerieux Vitek, Inc.
Microbiology · 123d
Cleared Apr 08, 1997
NATURAL-HIP SYSTEM COCR REVISION STEM
K970166 · LZO
Intermedics Orthopedics
Orthopedic · 82d
Cleared Apr 08, 1997
IS-ANTI-SSA TEST SYSTEM
K970218 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SM TEST SYSTEM
K970220 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
K970227 · JJE
Dpc Cirrus
Microbiology · 81d
Cleared Apr 08, 1997
IS-ANTI-JO-1 TEST SYSTEM
K970228 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SSB TEST SYSTEM (720-260)
K970237 · LLL
Diamedix Corp.
Immunology · 77d