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
121–144 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 22, 2025
Tetra (TM-20)
K251105 · PKP
Emed Technologies Corporation
General Hospital · 255d
Cleared Dec 22, 2025
KP Protective Face Mask
K243342 · FXX
Kp Trading Co., Ltd.
General Hospital · 423d
Cleared Dec 18, 2025
Midline Catheter
K252402 · PND
Terumo Medical Products Hangzhou Co.,...
General Hospital · 140d
Cleared Dec 17, 2025
DuoprossTM Smart Cap (Type I)
K252518 · FMF
Duopross Meditech Corporate
General Hospital · 128d
Cleared Dec 17, 2025
SURFLO Hybria Closed System Safety IV Catheter
K252398 · FOZ
Terumo Medical Products Hangzhou Co.,...
General Hospital · 139d
Cleared Dec 16, 2025
VR® Personal Protective Level 3 Gown (VR Gowns)
K252940 · QPC
PolyConversions, Inc.
General Hospital · 92d
Cleared Dec 16, 2025
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology
K252373 · LJS
Spectrum Vascular
General Hospital · 139d
Cleared Dec 12, 2025
Self-Seal Sterilization Pouch and Roll
K251177 · FRG
Guangdong Maidi Medical Co., Ltd.
General Hospital · 240d
Cleared Dec 12, 2025
EXEL Disposable Syringe
K251089 · FMF
Exelint International, Co.
General Hospital · 246d
Cleared Dec 12, 2025
VaporShield
K250847 · MEG
Vault Paragon Group, Inc.
General Hospital · 267d
Cleared Dec 11, 2025
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
K252941 · FXX
O&M Halyard, Inc.
General Hospital · 87d
Cleared Dec 10, 2025
Verisafe Safety Retractable Insulin Syringes
K250192 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 321d
Cleared Dec 05, 2025
ProSeal™ Transfer Injector (421120, 421130, 421140)
K251722 · ONB
Epic Medical Pte. , Ltd.
General Hospital · 184d
Cleared Dec 04, 2025
nSet+ Stabilization Set [6426733]
K251257 · FPA
Np Medical
General Hospital · 225d
Cleared Dec 03, 2025
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
K250564 · FYA
Yadu Medical (Henan) Co., Ltd.
General Hospital · 280d
Cleared Dec 02, 2025
0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
K250884 · NGT
Becton, Dickinson and Company
General Hospital · 253d
Cleared Nov 26, 2025
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
K252355 · PTI
Sb-Kawasumi Laboratories, Inc.
General Hospital · 120d
Cleared Nov 21, 2025
StaClear Syringe (SC250AN)
K251849 · QLY
Staclear, Inc.
General Hospital · 158d
Cleared Nov 21, 2025
Pen Injector Needle 32.5
K250700 · FMI
Terumo Corporation
General Hospital · 259d
Cleared Nov 18, 2025
Fluido Compact System
K252636 · LGZ
The Surgical Company International B.V.
General Hospital · 90d
Cleared Nov 18, 2025
ulricheasyINJECT Max 2M (XD 10140)
K252281 · IZQ
Ulrich GmbH & Co. KG
General Hospital · 119d
Cleared Nov 17, 2025
Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile...
K251141 · LZA
Mercator Medical (Thailand), Ltd.
General Hospital · 217d
Cleared Nov 14, 2025
Biomoneta Avata Rx
K251872 · FRF
Biomoneta Research Private Limited
General Hospital · 149d
Cleared Nov 14, 2025
Sterilization Trays
K251756 · KCT
Paragon Implant Mfg., LLC
General Hospital · 158d