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
82969–82992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 2000
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
K993332 · GGC
Gradipore , Ltd.
Hematology · 135d
Cleared Feb 16, 2000
ULTRASEAL XT PLUS
K993846 · EBC
Ultradent Products, Inc.
Dental · 96d
Cleared Feb 16, 2000
VANNA BATHING SYSTEM
K993872 · ILJ
Vancare, Inc.
Physical Medicine · 93d
Cleared Feb 16, 2000
TEMPOFIT, MODEL 02693
K994012 · EBG
Detax GmbH & Co. KG
Dental · 82d
Cleared Feb 16, 2000
HARDYDISK ERYTHROMYCIN, 15MCG
K994135 · JTN
Hardy Diagnostics
Microbiology · 71d
Cleared Feb 16, 2000
HARDYDISK NORFLOXACIN, 10MCG
K994150 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Feb 16, 2000
CASTLE SERIES 100HC STEAM STERILIZERS
K994314 · FLE
Getinge/Castle, Inc.
General Hospital · 56d
Cleared Feb 16, 2000
MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM
K994425 · HRX
Endius, Inc.
Orthopedic · 48d
Cleared Feb 16, 2000
HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT...
K994432 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 48d
Cleared Feb 15, 2000
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
K000116 · JJY
Consolidated Technologies, Inc.
Chemistry · 32d
Cleared Feb 15, 2000
LIGHTSPEED 2.0CT SCANNER SYSTEM
K000300 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Feb 15, 2000
VOYAGER 6.0 SOFTWARE OPTION
K000310 · HAW
Philips Medical Systems (Cleveland),...
Neurology · 14d
Cleared Feb 15, 2000
QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF...
K991395 · MQL
Advanced Reproductive Technologies
Obstetrics & Gynecology · 300d
Cleared Feb 15, 2000
WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L
K991396 · MQL
Sage Biopharma
Obstetrics & Gynecology · 300d
Cleared Feb 15, 2000
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K992662 · MSJ
Bayer Corp.
Chemistry · 190d
Cleared Feb 15, 2000
REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT
K993395 · HIS
Remed Pharma
Obstetrics & Gynecology · 130d
Cleared Feb 15, 2000
REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT
K993396 · HIS
Remed Pharma
Obstetrics & Gynecology · 130d
Cleared Feb 15, 2000
REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT
K993404 · HIS
Remed Pharma
Obstetrics & Gynecology · 130d
Cleared Feb 15, 2000
REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT
K993405 · HIS
Remed Pharma
Obstetrics & Gynecology · 130d
Cleared Feb 15, 2000
REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT
K993408 · HIS
Remed Pharma
Obstetrics & Gynecology · 130d
Cleared Feb 15, 2000
MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES
K994154 · JEY
KLS-Martin L.P.
Dental · 68d
Cleared Feb 15, 2000
HMP CONTROLS (TAS) RAPIDPOINT
K994159 · GGN
Cardiovascular Diagnostics, Inc.
Hematology · 68d
Cleared Feb 15, 2000
PLR SPLINED REVISION STEM
K994184 · LZO
Biomet, Inc.
Orthopedic · 67d
Cleared Feb 15, 2000
HARDYDISK MEZLOCILLIN 75MCG
K994212 · JTN
Hardy Diagnostics
Microbiology · 63d