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
81121–81144 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 2000
RAICHEM PHOSPORUS REAGENT
K003012 · CEO
Hemagen Diagnostics, Inc.
Chemistry · 29d
Cleared Oct 25, 2000
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
K003094 · LTJ
Qualigen, Inc.
Immunology · 22d
Cleared Oct 25, 2000
HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST
K003219 · ELR
Harald Nordin S.A
Dental · 9d
Cleared Oct 25, 2000
HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST
K003221 · ELR
Harald Nordin S.A
Dental · 9d
Cleared Oct 25, 2000
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
K994321 · JOL
Automatic Liquid Packaging, Inc.
General Hospital · 308d
Cleared Oct 24, 2000
PDT DOSECALCULATOR, MODEL 80000
K000418 · NDC
Retinalabs.Com
General Hospital · 259d
Cleared Oct 24, 2000
EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR
K000739 · ITI
Otto Bock Orthopedic Industry, Inc.
Physical Medicine · 231d
Cleared Oct 24, 2000
RADIOMED SOURCE
K001070 · KXK
Radiomed Corp.
Radiology · 204d
Cleared Oct 24, 2000
LIFE SCOPE P, MODEL BSM-4100 SERIES
K001693 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 144d
Cleared Oct 24, 2000
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · NFB
Invacare Corp.
Anesthesiology · 90d
Cleared Oct 24, 2000
ELRAN 01 SYSTEM
K002431 · GCJ
Envision Advanced Medical System, Ltd.
General & Plastic Surgery · 77d
Cleared Oct 24, 2000
SIMPLICITY SOFT INFUSION SET
K002492 · FPA
Sterling Medivations, Inc.
General Hospital · 71d
Cleared Oct 24, 2000
EQUITY
K002826 · EJT
Jensen Industries, Inc.
Dental · 43d
Cleared Oct 24, 2000
ANSPACH ANGLED MICRONOSE ATTACHMENT
K002903 · HBE
The Anspach Effort, Inc.
Neurology · 36d
Cleared Oct 24, 2000
DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE,...
K002975 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 32d
Cleared Oct 24, 2000
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
K003091 · LYZ
Medline Industries, Inc.
General Hospital · 21d
Cleared Oct 24, 2000
SOMATOM SMILE
K003152 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 24, 2000
HEATED HUMIDIFIER
K983783 · BTT
Pegasus Research Corp.
Anesthesiology · 728d
Cleared Oct 23, 2000
DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K000838 · LYY
P.T. Healthcare Glovindo
General Hospital · 223d
Cleared Oct 23, 2000
DMLC IV-ERGO
K001163 · IXI
3D Line USA, Inc.
Radiology · 196d
Cleared Oct 23, 2000
ELECSYS CA 15-3 TEST SYSTEM
K001468 · MOI
Roche Diagnostics Corp.
Immunology · 166d
Cleared Oct 23, 2000
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
K001741 · HRX
Radionics, Inc.
Orthopedic · 137d
Cleared Oct 23, 2000
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
K001990 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 116d
Cleared Oct 23, 2000
MR-III
K002261 · GAS
Smith & Nephew, Inc.
General & Plastic Surgery · 90d