Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
149545–149568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1985
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-
K850865 · FJI
Erika, Inc.
Gastroenterology & Urology · 33d
Cleared Apr 03, 1985
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L
K850866 · KDI
Erika, Inc.
Gastroenterology & Urology · 33d
Cleared Apr 03, 1985
URETERAL DILATOR & URETERAL STONE DISLODGER
K850954 · FFL
American Edwards Laboratories
Gastroenterology & Urology · 26d
Cleared Apr 03, 1985
INFUSION SLEEVE - OPHTHALMIC
K851009 · HQC
Medical Instrument Development...
Ophthalmic · 22d
Cleared Apr 03, 1985
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C
K851032 · KXT
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Apr 03, 1985
RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV
K851111 · KOA
The Huxley Instrument Corp.
Gastroenterology & Urology · 15d
Cleared Apr 03, 1985
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER
K851112 · KOA
The Huxley Instrument Corp.
Gastroenterology & Urology · 15d
Cleared Apr 03, 1985
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR
K851113 · KOA
The Huxley Instrument Corp.
Gastroenterology & Urology · 15d
Cleared Apr 02, 1985
MUFFLER GAS-AIR VENT UNIT
K832170 · KNT
Dr. Edward Richards
Gastroenterology & Urology · 636d
Cleared Apr 02, 1985
OSTEON BONE MINERAL ANALYZER
K843922 · KGI
Osteon, Inc.
Radiology · 179d
Cleared Apr 02, 1985
MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT
K844850 · FKQ
Medicorp, Inc.
Gastroenterology & Urology · 110d
Cleared Apr 02, 1985
TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF
K850004 · GZJ
Todd Medical, Inc.
Neurology · 90d
Cleared Apr 02, 1985
TECA MF-20 MICROVASCULAR DOPPLER
K850071 · IYN
Teca, Inc.
Radiology · 83d
Cleared Apr 02, 1985
LEECO CONCEP-7-BHCG IRMA
K850530 · JHI
Leeco Diagnostics, Inc.
Chemistry · 50d
Cleared Apr 02, 1985
LEECO CONCEP-7-BHCG EIA
K850531 · JHI
Leeco Diagnostics, Inc.
Chemistry · 50d
Cleared Apr 02, 1985
STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K850570 · JHI
American Dade
Chemistry · 48d
Cleared Apr 02, 1985
MODEL SERUM HCG ASSAY
K850730 · JHI
Monoclonal Antibodies, Inc.
Chemistry · 39d
Cleared Apr 02, 1985
TRI-MED MODEL 112 MOISTURE TRAP
K850745 · CCK
Tri-Med, Inc.
Anesthesiology · 36d
Cleared Apr 02, 1985
TRI-MED MODEL 126 SAMPLE LINE W/EXTENDED LIFE NAFI
K850746 · CCK
Tri-Med, Inc.
Anesthesiology · 36d
Cleared Apr 02, 1985
TRI-MED MODEL 105 SPECIAL AIRWAY ADAPTOR
K850747 · CCK
Tri-Med, Inc.
Anesthesiology · 36d
Cleared Apr 02, 1985
MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT
K850779 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 35d
Cleared Apr 02, 1985
DROPSTIRS - PLASTIC DISPOSABLE PIPET
K850800 · JQW
Berwick Medical Products, Inc.
Chemistry · 34d
Cleared Apr 02, 1985
EMIT D.A.U. PROPOXYPHENE ASSAY
K850920 · JXN
Syva Co.
Toxicology · 28d
Cleared Apr 01, 1985
PHYSIOLOGICAL MONITOR 2100
K844353 · DXN
Datascope Corp.
Cardiovascular · 143d