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
154609–154632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1984
CENTRAL VEIN CATHERIZATION TRAY CC-20
K834073 · FOZ
Packaging Technologies, Inc.
General Hospital · 95d
Cleared Feb 28, 1984
LABIAL CUSPID TUBE
K834392 · DZD
Alexotek Co.
Dental · 76d
Cleared Feb 28, 1984
DISPOSABLE ICP KIT DIFF. SIZES
K840003 · GWM
Codman & Shurtleff, Inc.
Neurology · 55d
Cleared Feb 27, 1984
HEMOCCULT-C
K832311 · KHE
Menley & James Laboratories
Chemistry · 228d
Cleared Feb 27, 1984
UNIVERSAL LINE-A-PLATE
K833056 · EBO
Laurentian Laboratories
Dental · 173d
Cleared Feb 27, 1984
UNIVERSAL FIX-A-PLATE
K833057 · EBO
Laurentian Laboratories
Dental · 173d
Cleared Feb 27, 1984
BIOSONICS SALIVARY TESTER
K833635
Meyer, Faller & Weisman
Dental · 133d
Cleared Feb 27, 1984
HYDROXYLINE
K833640 · EJK
George Taub Products & Fusion Co., Inc.
Dental · 133d
Cleared Feb 27, 1984
TITAN GEL SILVER STAIN SYSTEM
K833855 · CEF
Helena Laboratories
Pathology · 112d
Cleared Feb 27, 1984
MENISCAL SUTURING SYSTEM
K833943 · LXH
Dyonics, Inc.
Orthopedic · 104d
Cleared Feb 27, 1984
MODEL XLE
K834087 · IYO
Interad Systems, Inc.
Radiology · 166d
Cleared Feb 27, 1984
VACUUM REGULATOR 0-2000 MMHG VR-1000
K834224 · KDP
Trimeter Instrument Corp.
General Hospital · 83d
Cleared Feb 27, 1984
PBC EXTENSION SET
K834252 · FPA
Philadelphia Biologics Center
General Hospital · 82d
Cleared Feb 27, 1984
PBC IV SET NON-VENTED
K834253 · FPA
Philadelphia Biologics Center
General Hospital · 82d
Cleared Feb 27, 1984
PBC IV SET VENTED
K834254 · FPA
Philadelphia Biologics Center
General Hospital · 82d
Cleared Feb 27, 1984
MYCOPLASMA PNEUMONIAE CF ANTIGEN
K834338 · GSB
Hillcrest Biologicals
Microbiology · 77d
Cleared Feb 27, 1984
ENDIX RADICULAR BIOCERAMIC PIN
K834363 · ELS
C.B.S. Biotechnics, Inc.
Dental · 123d
Cleared Feb 27, 1984
SURGICAL INSTRUMENTS & ACCESSORIES
K834366 · EMH
C.B.S. Biotechnics, Inc.
Dental · 123d
Cleared Feb 27, 1984
CRANE MENISCAL SUTURE SET
K834369 · LXH
Acufex Microsurgical, Inc.
Orthopedic · 76d
Cleared Feb 27, 1984
MULHOLLAN ARTHROSCOPIC NEEDLE CARRIER
K834370 · LXH
Acufex Microsurgical, Inc.
Orthopedic · 76d
Cleared Feb 27, 1984
DENTURE BASE RESIN
K834409 · EBI
Dentsply Intl.
Dental · 75d
Cleared Feb 27, 1984
CK-NAC REAGENT
K834502 · CGS
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared Feb 27, 1984
DISCRETE CLINICAL ANALYZER
K834521 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 68d
Cleared Feb 27, 1984
VITEX P.D.A
K834560 · EJH
Jeneric Ind.
Dental · 61d