FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
81289–81312 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 05, 2000
ASCEND SPINAL FIXATION SYSTEM
K002069 · KWP
Spinal Innovations, LLC
Orthopedic · 90d
Cleared Oct 05, 2000
CATHCOR DESKTOP
K002137 · DQK
Siemens Elema AB
Cardiovascular · 83d
Cleared Oct 05, 2000
REFACTO LABORATORY STANDARD
K002350 · GGP
The Genetics Institute
Hematology · 64d
Cleared Oct 05, 2000
S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08
K002478 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 55d
Cleared Oct 05, 2000
XIA SPINE SYSTEM
K002505 · KWP
Howmedica Osteonics Corp.
Orthopedic · 51d
Cleared Oct 05, 2000
RANDOX MICROALBUMIN
K002674 · DDZ
Randox Laboratories, Ltd.
Chemistry · 38d
Cleared Oct 05, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K002751 · DQA
Masimo Corp.
Anesthesiology · 30d
Cleared Oct 05, 2000
ELECSYS DHEA-S CALSET
K002760 · JIS
Roche Diagnostics Corp.
Chemistry · 30d