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
157417–157440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 1983
DISPOS. MEDICATION NEBULIZER
K831270 · CAF
Hospitak, Inc.
Anesthesiology · 50d
Cleared Jun 08, 1983
NEY-ORO 60
K831280 · EJT
Deringer-Ney, Inc.
Dental · 57d
Cleared Jun 08, 1983
ULTIPORE PREBYPASS PLUS FILTER
K831286 · KRJ
Pall Biomedical Products Co.
Cardiovascular · 49d
Cleared Jun 08, 1983
PROTOTRO/PROTEOLYTIC ENZYME CONTROL
K831297 · JBQ
American Dade
Chemistry · 48d
Cleared Jun 08, 1983
PEEP SYSTEM D
K831301 · BYE
Draeger Medical, Inc.
Anesthesiology · 48d
Cleared Jun 08, 1983
PBI BHCG RIA KIT
K831302 · JHI
Pacific Biotech, Inc.
Chemistry · 48d
Cleared Jun 08, 1983
SOLUTION ADMIN. SETS W/FLASHBALL
K831311 · FPA
Travenol Laboratories, S.A.
General Hospital · 47d
Cleared Jun 08, 1983
COMPUR* M1100 HEMATRCRIT SYSTEM
K831318 · JPI
Worthington Diagnostic Systems
Hematology · 47d
Cleared Jun 08, 1983
NEO-PREGNOSTICON DUOCLON TUBE TEST
K831339 · JHJ
Organon, Inc.
Immunology · 44d
Cleared Jun 08, 1983
DRAIN-R-DRAPE(EYE
K831340 · HMT
Sur-Tech, Inc.
General Hospital · 44d
Cleared Jun 08, 1983
RIANEN PROLACTIN 125I KIT
K831345 · CFT
New England Nuclear
Chemistry · 44d
Cleared Jun 08, 1983
ASTRA SYSTEMS ENZYME MODULE
K831353 · CFJ
Beckman Instruments, Inc.
Chemistry · 43d
Cleared Jun 08, 1983
DATA-ZYME ALKALINE PHOSPHATASE PROCED
K831360 · CJE
Data Medical Associates, Inc.
Microbiology · 43d
Cleared Jun 08, 1983
SOMATRON
K831394 · JFB
Somatron Co.
Physical Medicine · 40d
Cleared Jun 08, 1983
LINEAR ENZMATIC URIC ACID SYSTEM
K831398 · KNK
Simmler, Inc.
Chemistry · 40d
Cleared Jun 08, 1983
LOW PROFILE STEERABLE BALLOON DILATA
K831403 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 37d
Cleared Jun 08, 1983
SPEC IISX
K831413 · GZJ
Medical Devices, Inc.
Neurology · 37d
Cleared Jun 08, 1983
EMIT QST TOBRAMYCIN ASSAY
K831416 · LCD
Syva Co.
Toxicology · 36d
Cleared Jun 08, 1983
ORTHOPEDIC/NALEBUFF FINGER INSTRUMENTS
K831426
New England Surgical Instrument Corp.
Orthopedic · 36d
Cleared Jun 08, 1983
VENTRICULAR PACING LEADS MODELS 865/867
K831435 · DTB
Pacesetter Systems
Cardiovascular · 35d
Cleared Jun 08, 1983
UNIPOLAR ATRIAL J PACING LEAD MODEL 869
K831436 · DTB
Pacesetter Systems
Cardiovascular · 35d
Cleared Jun 08, 1983
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K831442 · DHB
Pharmacia, Inc.
Chemistry · 34d
Cleared Jun 08, 1983
SPIA SYS FOR SOLID PHASE IMMUNOASSAYS
K831448 · LIB
R&D Systems, Inc.
Chemistry · 34d
Cleared Jun 08, 1983
SILCATH CENTRAL CATHETER TRAY SIZE-
K831451 · JCY
Argon Medical Corp.
General & Plastic Surgery · 34d