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
1201–1224 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 12, 2022
Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free...
K220118 · LZA
Kl-Kepong Rubber Products Sdn. Bhd.
General Hospital · 118d
Cleared May 12, 2022
Sterile Hypodermic Syringes for Single Use
K213811 · FMF
Berpu Medical Technology Co., Ltd.
General Hospital · 156d
Cleared May 12, 2022
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
K210937 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 409d
Cleared May 11, 2022
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K220250 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 100d
Cleared May 11, 2022
Plus Medical Cover Gown
K213177 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 225d
Cleared May 11, 2022
Procedure Mask, Surgical Mask
K213001 · FXX
A Plus International, Inc.
General Hospital · 233d
Cleared May 10, 2022
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
K220428 · LZA
One Glove Industrial Sdn Bhd
General Hospital · 84d
Cleared May 10, 2022
White Nitrile Powder-Free Patient Examination Glove, Non Sterile
K220427 · LZA
One Glove Industrial Sdn Bhd
General Hospital · 84d
Cleared May 10, 2022
Needle Free Connector
K213004 · FPA
Medcaptain Life Science Co., Ltd.
General Hospital · 232d
Cleared May 06, 2022
Medline Orbis Chemo Surgical Gown
K214108 · FYA
Medline Industries, LP
General Hospital · 128d
Cleared May 05, 2022
Steriking Packaging for Medical Devices
K221016 · FRG
Wipak OY
General Hospital · 30d
Cleared May 05, 2022
Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
K212346 · FLL
Shenzhen Pango Medical Electronics...
General Hospital · 281d
Cleared May 05, 2022
Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1,...
K210565 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 434d
Cleared May 04, 2022
HydroPICC 5F Dual Lumen Catheter
K213550 · LJS
Access Vascular, Inc.
General Hospital · 177d
Cleared May 04, 2022
Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231,...
K212257 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 289d
Cleared May 04, 2022
Plus Medical Chemotherapy Gown
K211036 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 392d
Cleared May 03, 2022
Surgical and Prosthetic Trays
K220791 · KCT
Dentsply Sirona
General Hospital · 46d
Cleared May 03, 2022
Orchid Safety Release Valve(TM)
K212064 · QOI
Linear Health Sciences, LLC
General Hospital · 305d
Cleared Apr 29, 2022
Elite Biomedical Solutions Dose Request Cord
K220695 · MRZ
Elite Biomedical Solutions
General Hospital · 51d
Cleared Apr 29, 2022
Spectrum IQ Infusion System with Dose IQ Safety Software
K220417 · FRN
Baxter Healthcare Corporation
General Hospital · 74d
Cleared Apr 29, 2022
FreedomEdge Syringe Infusion System
K214045 · FRN
Repro-Medical System, Inc., Dba Koru...
General Hospital · 123d
Cleared Apr 29, 2022
SteriTite Container System with MediTray Products
K212711 · KCT
Case Medical, Inc.
General Hospital · 246d
Cleared Apr 29, 2022
Safety Pen Needle for Single Use, Insulin Pen Needles
K212514 · FMI
Berpu Medical Technology Co., Ltd.
General Hospital · 262d
Cleared Apr 29, 2022
Disposable Surgical Isolation Gown
K212422 · FYC
Crown Name Disposable Hygiene...
General Hospital · 268d