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
81889–81912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 10, 2000
ATOM INFA WARMER V-505
K002355 · FMT
Atom Medical Corp
General Hospital · 69d
Cleared Oct 10, 2000
MODEL 4815 ADAPTER
K002496 · DTN
Pace Medical
Cardiovascular · 57d
Cleared Oct 10, 2000
MODEL 4810 ANALYZER OUTPUT ADAPTER
K002497 · DTC
Pace Medical
Cardiovascular · 57d
Cleared Oct 10, 2000
LIGTHSPEED 3.0 CT SCANNER SYSTEM
K002978 · JAK
GE Medical Systems
Radiology · 15d
Cleared Oct 06, 2000
ACTICOAT 7 DRESSING
K001519 · FRO
Westaim Biomedical, Inc.
General & Plastic Surgery · 143d
Cleared Oct 06, 2000
RESUSCI INFLATE-A-SHIELD CPR BARRIER
K001742 · CBP
Laerdal Medical Corp.
Anesthesiology · 120d
Cleared Oct 06, 2000
SPEEDLINK TRANSVERSE CONNECTOR
K002082 · KWP
Spinal Concepts, Inc.
Orthopedic · 88d
Cleared Oct 06, 2000
BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
K002094 · ESW
C.R. Bard, Inc.
Gastroenterology & Urology · 87d
Cleared Oct 06, 2000
SPL CRIMP SYSTEM
K002110 · JDQ
Pioneer Surgical Technology
Orthopedic · 86d
Cleared Oct 06, 2000
PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X
K002228 · GEX
Paradigm Medical Industries, Inc.
General & Plastic Surgery · 74d
Cleared Oct 06, 2000
EEG SPIKE AND EVENT DETECTOR MODULE
K002332 · OMB
Excel Tech. , Ltd.
Neurology · 66d
Cleared Oct 06, 2000
ADVANTAGE DRIVE SYSTEM
K002523 · HBC
Linvatec Corp.
Neurology · 52d
Cleared Oct 06, 2000
SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)
K002557 · GAW
Axya Medical, Inc.
General & Plastic Surgery · 50d
Cleared Oct 06, 2000
INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM
K002592 · KWQ
Interpore Cross Intl.
Orthopedic · 46d
Cleared Oct 06, 2000
SYNTHES PROXIMAL HUMERAL NAIL
K002729 · JDS
Synthes (Usa)
Orthopedic · 35d
Cleared Oct 06, 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP...
K002939 · DQA
Masimo Corp.
Anesthesiology · 15d
Cleared Oct 06, 2000
BIOMET BI-POLAR SHOULDER SYSTEM
K002998 · KWT
Biomet, Inc.
Orthopedic · 10d
Cleared Oct 06, 2000
TUTOPATCH
K991296 · FTM
Tutogen Medical U.S., Inc.
General & Plastic Surgery · 540d
Cleared Oct 05, 2000
TDK HANDPIECES
K000848 · EFB
Orasystems
Dental · 204d
Cleared Oct 05, 2000
SPIROL EPIDURAL CATHETER
K000886 · BSO
Abbott Laboratories
Anesthesiology · 199d
Cleared Oct 05, 2000
I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
K001387 · CGA
I-Stat Corp.
Chemistry · 156d
Cleared Oct 05, 2000
REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)
K001603 · KLI
Repromedix Corp.
Chemistry · 134d
Cleared Oct 05, 2000
REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)
K001606 · JLW
Repromedix Corp.
Chemistry · 134d
Cleared Oct 05, 2000
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)
K001607 · CDP
Repromedix Corp.
Chemistry · 134d