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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
156697–156720 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 1983
STERILE IV SET 4 SIZES
K832329 · FPA
Abco Dealers, Inc.
General Hospital · 40d
Cleared Aug 24, 1983
DYNACOR CONNECTING TUBING
K832398 · BYY
Medline Industries, Inc.
General Hospital · 35d
Cleared Aug 18, 1983
AOR X-RAY ALIGMENT PAD
K837776 · IXJ
Zimmer, Inc.
Radiology · 229d
Cleared Aug 16, 1983
FITKIT I CHECKUP KIT
K821799 · CDM
Patton, Boggs & Blow
Chemistry · 424d
Cleared Aug 16, 1983
FITKIT I CHECKUP KIT
K830340 · CDM
Boditestor
Hematology · 195d
Cleared Aug 16, 1983
AMBULATORY MARK III INFUSION DEVICE
K830656 · FRN
Windsor Medical, Inc.
General Hospital · 167d
Cleared Aug 16, 1983
P.C.A. UNICOMPARTMENTAL KNEE PROSTHES
K831143 · HRY
Howmedica Corp.
Orthopedic · 131d
Cleared Aug 16, 1983
ANCHOR BRAND SURGICAL NEEDLES
K831648 · GAB
Anchor Products Co.
General & Plastic Surgery · 85d
Cleared Aug 16, 1983
CONTINU-FLO SOLUTION ADMINISTRATION
K831668 · FPB
Travenol Laboratories, S.A.
General Hospital · 85d
Cleared Aug 16, 1983
FOIL IN 3 FORMS-NON-STERILE SHEETS
K831725 · FTM
S. Jackson, Inc.
General & Plastic Surgery · 77d
Cleared Aug 16, 1983
IMPLANTABLE PROGRAM. CARDIAC PULSE GEN
K831771 · DXY
Telectronics, Inc.
Cardiovascular · 75d
Cleared Aug 16, 1983
MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK
K831773 · HQJ
Bcd Products, Inc.
Ophthalmic · 75d
Cleared Aug 16, 1983
SETS & TRAYS
K831794
I M, Inc.
General & Plastic Surgery · 74d
Cleared Aug 16, 1983
TEXAS INTERFACE PRESSURE EVALUATOR-TIPE
K831800 · JFC
Tee-Kay Applied Technology
Physical Medicine · 85d
Cleared Aug 16, 1983
INSPIREASE
K832037 · CCQ
Key Pharmaceuticals, Inc.
Anesthesiology · 53d
Cleared Aug 16, 1983
EVOKED 3500 POTENTIAL SYSTEM
K832084 · GWE
Tracor Northern, Inc.
Neurology · 49d
Cleared Aug 16, 1983
LENSOMETER
K832085
CooperVision, Inc.
Ophthalmic · 49d
Cleared Aug 16, 1983
A.M.S. TEMP. SCAN 300
K832135 · FLL
Andon Medical Systems, Inc.
General Hospital · 46d
Cleared Aug 16, 1983
TA-400 TEMP. FEEDBACK DEVICE
K832146 · HCC
Spectral Data Systems
Neurology · 42d
Cleared Aug 16, 1983
DHEA-SULFATE I RIA KIT
K832154 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 42d
Cleared Aug 16, 1983
CHOLESTEROL HIGH PERFORMANCE-K
K832158 · CHH
Boehringer Mannheim Corp.
Chemistry · 42d
Cleared Aug 16, 1983
UNITIZED ENZYMATIC GLUCOSE TEST SET
K832159 · CGA
Stanbio Laboratory
Chemistry · 42d
Cleared Aug 16, 1983
FLO-GARD 8500 MICROINFUSION PUMP
K832166 · FRN
Travenol Laboratories, S.A.
General Hospital · 42d
Cleared Aug 16, 1983
CORPAK VTR 300 ENTERNAL PUMP
K832167 · FRN
Corpak Co.
General Hospital · 42d