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
769–792 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 15, 2023
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs...
K230121 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 118d
Cleared May 13, 2023
Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with...
K230217 · KGO
Grand Work Plastic Products Co., Ltd.
General Hospital · 107d
Cleared May 12, 2023
BD Secondary Infusion Set
K223101 · FPA
Care Fusion
General Hospital · 224d
Cleared May 10, 2023
Digital Thermometer (Model QT001)
K223044 · FLL
Shen Zhen Rong Feng Technology Co., Ltd.
General Hospital · 223d
Cleared May 09, 2023
Tyvek Roll with CI for STERLINK Sterilizer
K223025 · FRG
Plasmapp Co,., Ltd.
General Hospital · 222d
Cleared May 09, 2023
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators...
K223023 · FRC
Plasmapp Co,., Ltd.
General Hospital · 222d
Cleared May 09, 2023
STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
K223015 · MLR
Plasmapp Co,., Ltd.
General Hospital · 222d
Cleared May 09, 2023
Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for...
K212857 · FMF
Jiangsu Zhiyu Medical Instrument Co,...
General Hospital · 608d
Cleared May 08, 2023
Disposible Nitrile Gloves
K223280 · LZA
Holik Asia Group Co.,Ltd
General Hospital · 196d
Cleared May 05, 2023
Polyguard and Polyshield Safety IV Catheters
K230616 · FOZ
Poly Medicure Limited
General Hospital · 60d
Cleared May 05, 2023
Lexa MINI (RIS-303, RIS-305)
K223858 · FLE
W&H Sterilization S.R.L.
General Hospital · 133d
Cleared May 04, 2023
Orchid Safety Release Valve
K230266 · QOI
Linear Health Sciences, LLC
General Hospital · 93d
Cleared May 04, 2023
Sol-Guard Auto-disable Syringe
K220713 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 419d
Cleared May 01, 2023
RIA Safeguard
K222416 · FRF
Ria Tech Co., Ltd.
General Hospital · 264d
Cleared Apr 28, 2023
Kurin Blood Culture Collection Set with Kurin Lock Technology
K220677 · JKA
Kurin, Inc.
General Hospital · 416d
Cleared Apr 27, 2023
PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke...
K230547 · GEI
Conmed Corporation
General Hospital · 58d
Cleared Apr 27, 2023
Biodegradable Powder Free Nitrile Examination Glove, Blue Color,...
K221983 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 295d
Cleared Apr 26, 2023
SafeAir combi (SFR-combi-US)
K223932 · GEI
Lina Medical Aps
General Hospital · 117d
Cleared Apr 20, 2023
Neodent Implant System - Helix Short Surgical Kit Cases
K223662 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 135d
Cleared Apr 19, 2023
NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse...
K220288 · FPA
Np Medical, Inc.
General Hospital · 442d
Cleared Apr 14, 2023
OSPREY PERIPHERAL IV Catheter System
K223018 · FOZ
Skydance Vascular, Inc.
General Hospital · 197d
Cleared Apr 14, 2023
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for...
K220345 · MLR
Plasmapp Co,., Ltd.
General Hospital · 431d
Cleared Apr 13, 2023
Sterile Nitrile Surgical Gloves Powder Free
K222350 · KGO
Jr Engineering & Medical Technologies...
General Hospital · 253d
Cleared Apr 12, 2023
Polyfusion IV Administration Sets
K220312 · FPA
Poly Medicure Limited
General Hospital · 434d