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: General Hospital ×
17,825 results
409–432 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 18, 2024
Perpak™ Sterilization Tyvek Pouch
K241123 · FRG
Km Corp.
General Hospital · 148d
Cleared Sep 18, 2024
LOWTEM Crystal 120
K231893 · MLR
Lowtem Co., Ltd.
General Hospital · 448d
Cleared Sep 18, 2024
Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene®...
K231383 · FRC
Terragene S.A.
General Hospital · 495d
Cleared Sep 17, 2024
Medline Reusable Sterilization Wrappers
K234132 · FRG
Medline Industries, LP
General Hospital · 264d
Cleared Sep 16, 2024
HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization...
K234050 · FRG
O&M Halyard, Inc.
General Hospital · 270d
Cleared Sep 12, 2024
3M™ Attest™ Super Rapid Readout Biological Indicator 1492V
K241710 · FRC
3M Company
General Hospital · 90d
Cleared Sep 11, 2024
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46...
K241745 · LZA
Ksg Medicare Sdn. Bhd.
General Hospital · 85d
Cleared Sep 10, 2024
ProPel SG3™ Surgical Gown
K241214 · FYA
Standard Textile Co., Inc.
General Hospital · 133d
Cleared Sep 09, 2024
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
K240266 · LYY
Sri Trang Gloves (Thailand) Public...
General Hospital · 222d
Cleared Sep 06, 2024
nextaro® va, 15mm, 5µm
K241976 · LHI
Sfm Medical Devices GmbH
General Hospital · 63d
Cleared Sep 06, 2024
Orchid Safety Release Valve™
K241415 · QOI
Linear Health Sciences, LLC
General Hospital · 112d
Cleared Sep 05, 2024
Novum IQ Syringe Pump (40800BAXUS)
K242390 · FRN
Baxter Healthcare Corporation
General Hospital · 24d
Cleared Sep 05, 2024
ProGear® Surgical Mask with Oxafence®, Model AV82030
K231741 · OUK
Prestige Ameritech
General Hospital · 449d
Cleared Sep 04, 2024
Tamper Evident Cap
K231095 · FMF
International Medical Industries, Inc.
General Hospital · 505d
Cleared Aug 30, 2024
ToxiSeal™ Vial Adaptor
K241823 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 67d
Cleared Aug 28, 2024
GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with...
K240545 · LZA
Genabio Diagnostics, Inc.
General Hospital · 183d
Not Cleared Aug 28, 2024
Chronos®
DEN230067 · SCS
Germitec
General Hospital · 335d
Cleared Aug 27, 2024
Disposable Syringe (Kit)
K242212 · DXT
Nemoto Kyorindo Co., Ltd.
General Hospital · 29d
Cleared Aug 26, 2024
ulricheasyINJECT Max 2M (XD 10140)
K241850 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 60d
Cleared Aug 26, 2024
PRIMED Surgical Masks and PRIMED Procedure Masks
K240286 · FXX
Primed Medical Products, Inc.
General Hospital · 207d
Cleared Aug 23, 2024
Cardinal Health Nitrile Exam Gloves
K241780 · LZA
Cardinal Health200, LLC
General Hospital · 64d
Cleared Aug 23, 2024
Guided Surgery Kit Cases
K241492 · KCT
JJGC Ind?stria e Com?rcio de...
General Hospital · 87d
Cleared Aug 23, 2024
Polyisoprene Surgical gloves
K240790 · KGO
Suzhou Colour-Way New Material Co., Ltd.
General Hospital · 154d
Cleared Aug 22, 2024
I.V. Administration Set
K242126 · FPA
Bq Plus Medical Co., Ltd.
General Hospital · 34d