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

80 results for "Thermo Fisher Scientific"
49–72 of 80
Search insights Median review: 92d Cleared: 99% Top manufacturer: Thermo Fisher Scientific Lead specialty: Microbiology
Cleared Sep 27, 2018
Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30
K181975 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 65d
Cleared Aug 08, 2018
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in...
K181946 · JWY
Thermo Fisher Scientific
Microbiology · 19d
Cleared Dec 01, 2017
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K173209 · JWY
Thermo Fisher Scientific
Microbiology · 60d
Cleared Oct 13, 2017
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K172454 · JWY
Thermo Fisher Scientific
Microbiology · 60d
Cleared Aug 30, 2017
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC...
K172274 · JWY
Thermo Fisher Scientific
Microbiology · 33d
Cleared Aug 01, 2017
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K171870 · JWY
Thermo Fisher Scientific
Microbiology · 40d
Cleared Dec 21, 2015
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K152774 · JWY
Thermo Fisher Scientific
Microbiology · 87d
Cleared Aug 28, 2015
Sensititre 18-24 hours MIC or BP Susceptibility System with...
K150556 · JWY
Thermo Fisher Scientific
Microbiology · 177d
Cleared Jul 27, 2015
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with...
K150236 · JWY
Thermo Fisher Scientific
Microbiology · 175d
Cleared Apr 01, 2015
Sensititre Susceptibility plates
K143288 · JWY
Thermo Fisher Scientific
Microbiology · 135d
Cleared Mar 05, 2015
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
K143526 · JWY
Thermo Fisher Scientific
Microbiology · 83d
Cleared Mar 02, 2015
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)
K142338 · JWY
Thermo Fisher Scientific
Microbiology · 193d
Cleared Feb 19, 2015
Sensititre Susceptibility Plates
K143381 · JWY
Thermo Fisher Scientific
Microbiology · 86d
Cleared Dec 23, 2014
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K142151 · JWY
Thermo Fisher Scientific
Microbiology · 139d
Cleared Oct 21, 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141651 · JWY
Thermo Fisher Scientific
Microbiology · 123d
Cleared Aug 01, 2014
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES
K133847 · JWY
Thermo Fisher Scientific
Microbiology · 226d
Cleared Jul 16, 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141000 · JWY
Thermo Fisher Scientific
Microbiology · 89d
Cleared Jun 10, 2014
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES
K140985 · JWY
Thermo Fisher Scientific
Microbiology · 55d
Cleared May 22, 2014
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
K141220 · NSU
Thermo Fisher Scientific (Life...
Microbiology · 10d
Cleared Feb 27, 2014
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
K133773 · JWY
Thermo Fisher Scientific
Microbiology · 77d
Cleared Jan 29, 2013
IMMUNOCAP ALLERGEN K82
K121463 · DHB
Thermo Fisher Scientific
Immunology · 257d
Cleared Jul 15, 2010
REMEL SPECTRA VRE
K092819 · JSO
Thermo Fisher Scientific
Microbiology · 304d
Cleared Sep 18, 2009
NUNC IVF CENTERWELL AND ICSI DISHES
K090429 · MQK
Thermo Fisher Scientific (Nalge Nunc...
Obstetrics & Gynecology · 211d
Cleared Aug 26, 2009
XPECT FLU A & B
K092423 · PSZ
Thermo Fisher Scientific
Microbiology · 19d