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

Filters: Cleared only ×
176,076 results
171361–171384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1978
ARCOBIOLITH PACEMAKER MODEL
K780776 · DXY
Arco Medical Products Co.
Cardiovascular · 148d
Cleared Oct 03, 1978
DEVIN-NESTOR PNEUMATIC TOURNIQUET
K780988 · KCY
Nestor Engineering Associates, Inc.
General & Plastic Surgery · 111d
Cleared Oct 03, 1978
DEVIN-NESTOR SQUARE KNIFE
K780989 · EMF
Nestor Engineering Associates, Inc.
General & Plastic Surgery · 111d
Cleared Oct 03, 1978
STAINLESS STEEL TEMPLATE
K780990
Nestor Engineering Associates, Inc.
General & Plastic Surgery · 111d
Cleared Oct 03, 1978
PARALLEL BLADE MARKER
K780991 · EMF
Nestor Engineering Associates, Inc.
General & Plastic Surgery · 111d
Cleared Oct 03, 1978
THC DIRECT RIA KIT
K781048 · LAT
Immunalysis Corporation
Toxicology · 104d
Cleared Oct 03, 1978
GENERATORS, PULSE, MODELS 5988/5989
K781208 · DXY
Medtronic Vascular
Cardiovascular · 81d
Cleared Oct 03, 1978
GENERATOR, PULSE, MODEL 5997
K781252 · DXY
Medtronic Vascular
Cardiovascular · 74d
Cleared Oct 03, 1978
THERAPY UNIT & ELECTRODIAG.
K781314 · GXY
General Theraphysical, Inc.
Neurology · 64d
Cleared Oct 03, 1978
MUSCLE STIMULATION APPARATUS
K781315 · IPF
General Theraphysical, Inc.
Physical Medicine · 64d
Cleared Oct 03, 1978
ULTRASONIC THERAPY APPARATUS, 407
K781317 · IMI
General Theraphysical, Inc.
Physical Medicine · 64d
Cleared Oct 03, 1978
DYNATRON 406 ELECTROTHERAPY APPARATUS
K781318 · IPF
General Theraphysical, Inc.
Physical Medicine · 64d
Cleared Oct 03, 1978
THERAPY APPAR. 422 INTERFERENTIAL
K781319 · IPF
General Theraphysical, Inc.
Physical Medicine · 64d
Cleared Oct 03, 1978
FOCISCAN ECHOVISOR SYSTEM
K781348
Metrix Teknika, Inc.
Obstetrics & Gynecology · 57d
Cleared Oct 03, 1978
MICRODILUTION STREP ID. PANEL
K781367 · JSS
Cnr Labs
Microbiology · 56d
Cleared Oct 03, 1978
MICRODILUTION GRAM-NEGATIVE ID. PANEL
K781368 · JSS
Cnr Labs
Microbiology · 56d
Cleared Oct 03, 1978
MICRODILUTION ANAEROBE ID. PANEL
K781369 · JSF
Cnr Labs
Microbiology · 56d
Cleared Oct 03, 1978
SPECIALTY SPONGES
K781420 · EFQ
Ipco Corp.
General & Plastic Surgery · 49d
Cleared Oct 03, 1978
STAT ULTRA VIOLET LIQUID
K781432 · JHS
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Oct 03, 1978
DELTA TEST ASSAY, HDL CHLORESTEROL
K781436
Bd Becton Dickinson Vacutainer...
Chemistry · 46d
Cleared Oct 03, 1978
BECKMAN ASTRA SYSTEM
K781442 · JJF
Beckman Instruments, Inc.
Chemistry · 41d
Cleared Oct 03, 1978
AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT
K781466 · CDT
Fisher Scientific Co., LLC
Chemistry · 40d
Cleared Oct 03, 1978
TRIGLYCERIDES TEST KIT
K781477 · CDT
Mallinckrodt Critical Care
Chemistry · 36d
Cleared Oct 03, 1978
ACID PHOSPHATASE DIAG. KIT
K781489 · CJN
Sclavo, Inc.
Hematology · 36d