Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
145–168 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 12, 2026
Disposable Surgical Face Mask (3P00B, C2900)
K252830 · FXX
Beatles Medical Supplies (Xiantao)...
General Hospital · 129d
Cleared Jan 09, 2026
KabiHelp® Uno
K251139 · KPE
Fresenius Kabi AG
General Hospital · 270d
Cleared Jan 08, 2026
Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P,...
K251160 · FLL
Shenzhen Med-Link Electronics Tech...
General Hospital · 268d
Cleared Jan 06, 2026
Pen Needle
K252886 · FMI
Hh Global Technology, Inc.
General Hospital · 118d
Cleared Jan 05, 2026
Disposable Medical Face Mask
K252650 · FXX
Makrite Industries, Inc.
General Hospital · 136d
Cleared Dec 30, 2025
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
K250168 · FLE
Lucas Lifecare
General Hospital · 343d
Cleared Dec 23, 2025
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016)
K251991 · JOJ
Shenzhen Safesecure Medical Infection...
General Hospital · 179d
Not Cleared Dec 23, 2025
QIKCAP System
DEN250004 · SGX
Hai Solutions
General Hospital · 327d
Cleared Dec 22, 2025
Instylla Delivery Kit
K253769 · FMF
Instylla, Inc.
General Hospital · 27d
Cleared Dec 22, 2025
Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
K253222 · MMK
Zhejiang Gongdong Medical Technology...
General Hospital · 84d
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