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
141481–141504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 1987
ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER
K864532 · JPA
Medical Laboratory Automation...
Hematology · 81d
Cleared Feb 06, 1987
ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER
K864534 · JPA
Medical Laboratory Automation...
Hematology · 81d
Cleared Feb 06, 1987
ARTEL DIFFERENTIAL PHOTOMETER
K864542 · JJQ
Artel, Inc.
Chemistry · 79d
Cleared Feb 06, 1987
H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
K864664 · KSA
Technicon Instruments Corp.
Hematology · 70d
Cleared Feb 06, 1987
ANATOMIC MODULAR KNEE (AMK) SYSTEM
K864671 · JWH
Depuy, Inc.
Orthopedic · 66d
Cleared Feb 06, 1987
NAMIC CHIBA ASPIRATION BIOPSY NEEDLE
K864800 · GAA
North American Instrument Corp.
General & Plastic Surgery · 59d
Cleared Feb 06, 1987
IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS
K865000 · LET
Sclavo, Inc.
Toxicology · 46d
Cleared Feb 06, 1987
A-BEC FIREBALL 40
K865001 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 18
K865002
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 46
K865003 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 40 POWER WHEELCHAIR
K865004 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 41
K865005 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 14
K865006 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 15
K865007 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 17
K865008 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
A-BEC 47
K865009 · ITI
A-Bec Mobility, Inc.
Physical Medicine · 46d
Cleared Feb 06, 1987
BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM
K865021 · JTA
Bd Becton Dickinson Vacutainer...
Microbiology · 45d
Cleared Feb 06, 1987
ABBOTT LIFECARE (R) 5000, PUMP SYSTEM
K865058 · FRN
Abbott Laboratories
General Hospital · 44d
Cleared Feb 06, 1987
I.V. SET W/SINGLE-CHANNEL CASSETTE
K865059 · FRN
Abbott Laboratories
General Hospital · 44d
Cleared Feb 06, 1987
I.V. SET WITH DUAL-CHANNEL CASSETTE
K865060 · FRN
Abbott Laboratories
General Hospital · 44d
Cleared Feb 06, 1987
HCI GENERAL PURPOSE CATHETER STYLET
K870014 · KGZ
Health Care Innovations, Inc.
General & Plastic Surgery · 35d
Cleared Feb 06, 1987
HCI ALL PURPOSE DRAIN/CATHETER SET
K870015 · GBS
Health Care Innovations, Inc.
General & Plastic Surgery · 35d
Cleared Feb 06, 1987
TECNOL CLASSIC CONE MASK
K870056 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 30d
Cleared Feb 06, 1987
LITHOTOMY HOLDERS
K870098 · FWZ
Orthopedic Systems, Inc.
General & Plastic Surgery · 28d