FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
105697–105720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1995
MODEL 2730 CLINICAL REFRACTOMETER
K941906 · JRE
Vee Gee Scientific, Inc.
Chemistry · 273d
Cleared Jan 17, 1995
THE KARL STORZ ARTHROPUMP
K942298 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 250d
Cleared Jan 17, 1995
AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT
K942661 · JLW
Sealite Sciences, Inc.
Chemistry · 225d
Cleared Jan 17, 1995
KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM
K942664 · JOW
The Kendal Co.
Cardiovascular · 225d
Cleared Jan 17, 1995
EASY LYTE CALCIUM ANALYZER
K943091 · JFP
Medica Corp.
Chemistry · 203d
Cleared Jan 17, 1995
HEMOCUE B-GLUCOSE SYSTEM
K943432 · CGA
Hemocue, Inc.
Chemistry · 186d
Cleared Jan 17, 1995
QUANITITATE GBCC VERIFIER SET
K944454 · JJY
Beckman Instruments, Inc.
Chemistry · 127d
Cleared Jan 17, 1995
QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE)
K944455 · JJY
Beckman Instruments, Inc.
Chemistry · 127d
Cleared Jan 17, 1995
SAS QUANT HCG SERUM
K944785 · JJX
Sa Scientific, Inc.
Chemistry · 111d
Cleared Jan 17, 1995
VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
K945172 · HQX
Visitec Co.
Ophthalmic · 88d
Cleared Jan 17, 1995
THEOPHYLLINE CALIBRATORS
K945338 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 77d
Cleared Jan 17, 1995
CEDIA DAU OPIATE ASSAY
K945343 · DJG
Microgenics Corp.
Toxicology · 77d
Cleared Jan 17, 1995
CEDIA DAU COCAINE ASSAY
K945345 · DIO
Microgenics Corp.
Toxicology · 77d
Cleared Jan 17, 1995
PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT
K945378 · EBC
Pulpdent Corp.
Dental · 76d
Cleared Jan 17, 1995
HCG MIDSTREAM PREGNANCY TEST
K945568 · LCX
Mizuho USA, Inc.
Chemistry · 68d
Cleared Jan 17, 1995
RI-SCOPE S OTOSCOPE
K945640 · HLJ
Rudolf Riester GmbH & Co. KG
Ophthalmic · 62d
Cleared Jan 17, 1995
DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET
K945718 · JJX
Casco Standards
Chemistry · 57d
Cleared Jan 17, 1995
ELASTYREN(R) SURGICAL GLOVES
K945833 · KGO
Eci Medical Technologies, Inc.
General Hospital · 49d
Cleared Jan 17, 1995
SPECTRUM CO-OXIMETER LINEARITY CONTROL
K945860 · JJS
Phoenix Diagnostics, Inc.
Chemistry · 47d
Cleared Jan 17, 1995
SUNGLASSES
K945920 · HQY
Glendale Protective Technologies, Inc.
Ophthalmic · 43d
Cleared Jan 17, 1995
EYEWEAR/SPECTACLES
K945925 · HQY
Kovision Mfg., Ltd.
Ophthalmic · 43d
Cleared Jan 17, 1995
CEDIA(R) DAU PCP ASSAY
K946059 · LCM
Microgenics Corp.
Toxicology · 36d
Cleared Jan 17, 1995
KODAK EKTACCHEM 950IRC ANALYZER
K946090 · JJE
Clinical Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jan 17, 1995
PASCO MIC AND MIC/ID PANELS
K946126 · JWY
Pasco Laboratories, Inc.
Microbiology · 33d