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
2161–2184 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 20, 2020
TidalPort-AP Implantable Apheresis Vascular Access Port
K192291 · PTD
Norfolk Medical Products, Inc.
General Hospital · 363d
Cleared Aug 19, 2020
Asept Surgical Face Mask
K201137 · FXX
Pfm Medical, Inc.
General Hospital · 113d
Cleared Aug 12, 2020
Surgical Mask
K201871 · FXX
C & S Paper Yunfu Co., Ltd.
General Hospital · 36d
Cleared Aug 12, 2020
BD PhaSeal Optima Closed System Drug Transfer Device
K201099 · ONB
Becton, Dickinson and Company
General Hospital · 110d
Cleared Aug 11, 2020
0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1...
K201286 · NGT
Nurse Assist, LLC
General Hospital · 89d
Cleared Aug 10, 2020
1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle,...
K192551 · MEG
Jiangsu Caina Medical Co.,Ltd
General Hospital · 328d
Cleared Aug 07, 2020
MedSource CathMED IV Catheter
K193278 · FOZ
Medsource Labs
General Hospital · 254d
Cleared Aug 07, 2020
Sterile High-pressure Angiographic Syringes for Single-use
K192657 · DXT
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 317d
Cleared Aug 07, 2020
ProSeal™ Closed System drug Transfer Device (CSTD)
K192075 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 371d
Cleared Aug 06, 2020
Mini Sterilizable Tray
K200858 · KCT
Implant Direct Sybron Manufacturing, LLC
General Hospital · 127d
Cleared Aug 06, 2020
Steripack cases and Tray Systems
K193066 · KCT
Avalign Technologies, Inc.
General Hospital · 276d
Cleared Aug 06, 2020
TK Safety Needle
K191644 · FMI
Anhui Tiankang Medical Technology...
General Hospital · 414d
Cleared Aug 05, 2020
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
K201531 · LZA
Hartalega Sdn Bhd
General Hospital · 58d
Cleared Aug 05, 2020
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K201530 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 58d
Cleared Aug 05, 2020
Modular Toga
K200977 · FYA
Operating Room Innovations, Inc.
General Hospital · 114d
Cleared Aug 04, 2020
Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy...
K193666 · LZA
Medline Industries, Inc.
General Hospital · 217d
Cleared Jul 30, 2020
MEDRAD Imaging Bulk Package Transfer Spike
K200280 · PQH
Bayer Medical Care, Inc.
General Hospital · 177d
Cleared Jul 29, 2020
Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN...
K200824 · FYA
Cardinal Health200, LLC
General Hospital · 121d
Cleared Jul 28, 2020
Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein...
K192681 · FPA
Jiangsu Kangbao Medical Equipment...
General Hospital · 306d
Cleared Jul 27, 2020
StaClear Syringe
K200242 · QLY
Tribofilm Research, Inc.
General Hospital · 178d
Cleared Jul 24, 2020
DemeMASK
K201479 · FXX
Demetech Corporation
General Hospital · 50d
Cleared Jul 24, 2020
Disposable Temperature Probe
K193625 · FLL
Shenzhen Changke Connect Electronics...
General Hospital · 211d
Cleared Jul 22, 2020
Empty EVA Bag
K193528 · KPE
Haemotronic S.P.A.
General Hospital · 216d
Cleared Jul 20, 2020
Benesta Medical Sterilization Tray
K193603 · KCT
Caldera Medical, Inc.
General Hospital · 210d