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
673–696 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 15, 2023
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource...
K223788 · FOZ
Medsource International, LLC
General Hospital · 270d
Cleared Sep 15, 2023
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead...
K221860 · QNQ
Poonglim Pharmatech, Inc.
General Hospital · 445d
Cleared Sep 14, 2023
PureWay 1.4 Quart Sharps Collector
K231484 · MMK
Pureway Compliance, Inc.
General Hospital · 114d
Cleared Sep 14, 2023
VitreJect® Needle
K230959 · FMI
Ocuject, LLC
General Hospital · 163d
Cleared Sep 13, 2023
AMSCO 600 Steam Sterilizer
K232485 · FLE
Steris
General Hospital · 28d
Cleared Sep 11, 2023
VERIFY Spore Test Strip for S40 Sterilant Concentrate
K231746 · OVY
STERIS Corporation
General Hospital · 88d
Cleared Sep 08, 2023
Sterile syringes for single use with/without needle
K231729 · FMI
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Sterile Auto-Disable Syringes with/without Needle for Single Use
K231727 · FMF
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Sterile Safety Hypodermic Needles for Single Use
K231723 · FMI
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Sterile Hypodermic Needles for Single Use
K231720 · FMI
Wepon Medical Technology Co., Ltd.
General Hospital · 87d
Cleared Sep 08, 2023
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with...
K231643 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 95d
Cleared Sep 08, 2023
VitreJect Syringe
K230372 · QLY
Ocuject, LLC
General Hospital · 207d
Cleared Sep 07, 2023
Steriking® LT-Blueline Pouches with Tyvek®
K231999 · FRG
Wipak OY
General Hospital · 64d
Cleared Sep 07, 2023
Steriking® LT-Blueline Pouches with Tyvek®
K231996 · FRG
Wipak OY
General Hospital · 64d
Cleared Sep 01, 2023
eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)
K223674 · KPE
Epic Medical Pte. , Ltd.
General Hospital · 268d
Not Cleared Sep 01, 2023
LightStrike+ (MXSUV1-SL and MXSUV1-FT)
DEN230007 · QXJ
Xenex Disinfection Services, Inc.
General Hospital · 212d
Cleared Aug 31, 2023
Powder Free Nitrile Examination Gloves (Black)
K232353 · LZA
Shanxi Hongjin Plastic Technology...
General Hospital · 24d
Cleared Aug 31, 2023
OSPREY Closed IV Catheter System (OspreyV2)
K231626 · FOZ
Skydance Vascular, Inc.
General Hospital · 90d
Cleared Aug 31, 2023
Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use...
K230578 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 183d
Cleared Aug 28, 2023
KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with...
K231435 · LZA
Kimberly Clark Corporation
General Hospital · 103d
Cleared Aug 25, 2023
NovoFine® Plus
K231255 · FMI
Novo Nordisk, Inc.
General Hospital · 116d
Cleared Aug 25, 2023
Reusable Temperature Probe, Disposable Temperature Probe
K223807 · FLL
Shenzhen Sino-K Medical Technology...
General Hospital · 248d
Cleared Aug 25, 2023
Sterilization Wrap
K223600 · FRG
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 266d
Cleared Aug 24, 2023
Instrument Case
K231604 · KCT
Cochlear Americas
General Hospital · 84d