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
649–672 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Aug 24, 2023
Plum Duo™ Infusion System
K223607 · FRN
Icu Medical, Inc.
General Hospital · 265d
Cleared Aug 24, 2023
LifeShield™ Infusion Safety Software Suite
K223606 · PHC
Icu Medical, Inc.
General Hospital · 265d
Cleared Aug 24, 2023
Nitrile Patient Examination Gloves, Powder Free, Pink Color
K222103 · LZA
Shandong Yinghng Medical Products...
General Hospital · 402d
Cleared Aug 23, 2023
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown...
K230610 · FYA
Dongguan Shin YI Healthcare Products...
General Hospital · 170d
Cleared Aug 23, 2023
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low...
K230079 · KGO
Ansell Healthcare Products, LLC
General Hospital · 225d
Cleared Aug 22, 2023
Surgical Gown (S,M,L,XL,XXL,XXXL)
K231510 · FYA
Xiantao Zhibo Non-Woven Products Co.,...
General Hospital · 89d
Cleared Aug 18, 2023
Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim,...
K222993 · KGO
Sentienx Sdn Bhd
General Hospital · 324d
Cleared Aug 16, 2023
Guided Surgery Kit
K231087 · DZI
Implant Direct Sybron Manufacturing, LLC
General Hospital · 121d
Cleared Aug 16, 2023
Powdered Free Sterile Natural Rubber Latex Surgical Gloves
K230832 · KGO
The Egyptian Company For Medical &...
General Hospital · 142d
Cleared Aug 16, 2023
Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
K230577 · FYA
Medcare Saglik Urunleri Sanayi VE...
General Hospital · 168d