FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127633–127656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1990
DISPOSABLE RESPIRTORY KIT (MP-200)
K896885 · IYT
Medipart Jerry Alexander
Radiology · 80d
Cleared Feb 26, 1990
3M IV FLOW REGULATOR
K896907 · LDR
3M Company
General Hospital · 80d
Cleared Feb 26, 1990
SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM
K896951 · CGA
Medisense, Inc.
Chemistry · 73d
Cleared Feb 26, 1990
CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO.
K897026 · DWF
Canyon Medical Products
Cardiovascular · 69d
Cleared Feb 26, 1990
LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT
K897150 · CHI
Toyo Jozo Co., Ltd.
Chemistry · 62d
Cleared Feb 26, 1990
TCT-300S - UPGRADE
K900233 · JAK
Toshiba America Medical Systems, In.C
Radiology · 27d
Cleared Feb 26, 1990
PFM-90 CEILING TUBE SUPPORT
K900234 · IYB
Fischer Imaging Corp.
Radiology · 40d
Cleared Feb 26, 1990
REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175
K900251 · CEF
Helena Laboratories
Chemistry · 40d
Cleared Feb 26, 1990
HOFMANN-NAGEL (HOFNA) X-RAY TUBES
K900367 · ITY
Hofmann
Radiology · 31d
Cleared Feb 26, 1990
AIA-PACK BMG
K900440 · JZG
Tosoh Medics, Inc.
Immunology · 28d
Cleared Feb 26, 1990
DU PONT MAMMOGRAPHY CASSETTE
K900620 · IXA
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 18d
Cleared Feb 26, 1990
MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET
K900625 · KTN
Armkel, LLC
Immunology · 18d
Cleared Feb 26, 1990
BIODEX BACK SYSTEM ATTACHMENT
K900741 · IKK
Biodex Corp.
Physical Medicine · 10d
Cleared Feb 23, 1990
QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM
K894992 · MAA
Quantum Medical Systems, Inc.
Radiology · 199d
Cleared Feb 23, 1990
QUANTUM QAD-1E ANGIODYNOGRAPH ULTRASOUND SYSTEM
K895147 · IYO
Quantum Intl.
Radiology · 185d
Cleared Feb 23, 1990
HYPEX
K895274 · BYW
Global Business, Inc.
Anesthesiology · 184d
Cleared Feb 23, 1990
SXT-60F/60M MOBILE C ARM X-RAY UNIT
K896387 · OXO
Toshiba America Medical Systems, In.C
Radiology · 109d
Cleared Feb 23, 1990
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC
K896744 · JXM
Bio-Rad
Toxicology · 85d
Cleared Feb 23, 1990
CARBON DIOXIDE REAGENT
K896812 · KHS
Pointe Scientific, Inc.,
Chemistry · 81d
Cleared Feb 23, 1990
TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD)
K896829 · JGT
Technicon Instruments Corp.
Chemistry · 81d
Cleared Feb 23, 1990
MODEL BT-1 FOT BOLT INSTALLATION KIT
K896834 · GWM
Pearl Instruments Corp.
Neurology · 80d
Cleared Feb 23, 1990
THYROID STIMULATING HORMONE-EIA-XT
K896867 · JLW
In Vitro Diagnostics, Inc.
Chemistry · 79d
Cleared Feb 23, 1990
ALPHA-STIM CS
K896948 · GZJ
Electromedical Products, Inc.
Neurology · 72d
Cleared Feb 23, 1990
ABBOTT SPECTRUM URIC ACID REAGENT KIT
K896954 · KNK
Abbott Laboratories
Chemistry · 71d