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: General Hospital ×
17,791 results
385–408 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Aug 22, 2024
INSULCLOCK® v2.0 PRO
K241803 · QOG
Insulcloud S.L.
General Hospital · 62d
Cleared Aug 22, 2024
Single-use Sterile High-pressure Angiographic Syringes and Accessories
K241109 · DXT
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 122d
Cleared Aug 20, 2024
CELERITY HP Indicator Tape (PCC077)
K242189 · JOJ
Steris
General Hospital · 26d
Cleared Aug 20, 2024
Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)
K240077 · FLL
Covidien
General Hospital · 223d
Cleared Aug 15, 2024
Disposable Pen Injector Assembly
K240961 · FMF
Wuxi Nest Biotechnology Co., Ltd.
General Hospital · 129d
Cleared Aug 12, 2024
Ultravision2™ IonPencil
K240868 · PQM
Alesi Surgical Limited
General Hospital · 136d
Not Cleared Aug 12, 2024
SoClean 3+ Bacterial Reduction Device
DEN210037 · QXQ
Soclean, Inc.
General Hospital · 1062d
Cleared Aug 07, 2024
HALYARD* SMART-FOLD* Sterilization Wrap (H450)
K240330 · FRG
O&M Halyard, Inc.
General Hospital · 184d
Cleared Aug 06, 2024
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis...
K241528 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 68d
Cleared Aug 05, 2024
PlumeSafe X5 Smoke Management System
K240127 · FYD
Conmed Corporation
General Hospital · 201d