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
85489–85512 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 1999
MXU-125 OR TMX-125
K992229 · IZL
Trex Medical Corp.
Radiology · 35d
Cleared Aug 06, 1999
H20- TETHERED OPTION
K992291 · OLV
Grass-Telefactor Product Group
Neurology · 30d
Cleared Aug 06, 1999
VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
K992406 · GEI
Mitek Products
General & Plastic Surgery · 17d
Cleared Aug 05, 1999
DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE
K983618 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 294d
Cleared Aug 05, 1999
SILGEL STC-S
K984029 · MDA
Nagor , Ltd.
General & Plastic Surgery · 266d
Cleared Aug 05, 1999
RITEFLO SPACER
K984085 · CAF
Aeromax Technologies, Inc.
Anesthesiology · 262d
Cleared Aug 05, 1999
UROSTYM BIOFEEDBACK AND STIMULATION PROBES
K990041 · KPI
Laborie Medical Tech Corp.
Gastroenterology & Urology · 211d
Cleared Aug 05, 1999
HOFFMAN IVF-1
K991216 · MQG
(Arms) Hoffman Surgical Equipment,...
Obstetrics & Gynecology · 118d
Cleared Aug 05, 1999
ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE,...
K991261 · MQH
Research Instruments , Ltd.
Obstetrics & Gynecology · 114d
Cleared Aug 05, 1999
MAHE INSTRUMENTS
K991426 · FDC
Mahe Intl., Inc.
Gastroenterology & Urology · 104d
Cleared Aug 05, 1999
MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
K991505 · LCM
Microdiagnostics, Inc.
Toxicology · 98d
Cleared Aug 05, 1999
MICRO-STRIP FOR MARIJUANA METABOLITES
K991516 · LDJ
Microdiagnostics, Inc.
Toxicology · 97d
Cleared Aug 05, 1999
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
K991594 · MSB
Sangstat Medical Corp.
Gastroenterology & Urology · 90d
Cleared Aug 05, 1999
PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.
K991845 · LZA
Omnigrace , Ltd.
General Hospital · 69d
Cleared Aug 05, 1999
PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE
K991846 · LZA
Omnigrace , Ltd.
General Hospital · 69d
Cleared Aug 05, 1999
HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
K991871 · MKJ
Hewlett-Packard Co.
Cardiovascular · 65d
Cleared Aug 05, 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR
K991981 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 52d
Cleared Aug 05, 1999
AUTOHDL CHOLESTEROL REAGENT SET
K992002 · LBR
Pointe Scientific, Inc.,
Chemistry · 51d
Cleared Aug 05, 1999
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
K992017 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 51d
Cleared Aug 05, 1999
LAGLOVE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM...
K992019 · KGO
La Glove (M) Sdn. Bhd.
General Hospital · 50d
Cleared Aug 05, 1999
CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY
K992157 · DBF
Chiron Diagnostics Corp.
Immunology · 41d
Cleared Aug 05, 1999
FLEXISCOPE IQ 101
K992362 · FET
Schoelly Fiberoptic GmbH
Gastroenterology & Urology · 21d
Cleared Aug 04, 1999
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K973707 · MKZ
Roche Molecular Systems, Inc.
Microbiology · 674d
Cleared Aug 04, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
K991028 · FGE
Cordis Corp.
Gastroenterology & Urology · 128d