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
97–120 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 13, 2026
Babyleo TN500
K251619 · FMZ
Dr?gerwerk AG & Co KGaA
General Hospital · 262d
Cleared Feb 12, 2026
PuraCath Firefly Needleless Connector IT (9005)
K251375 · FPA
Puracath Medical, Inc.
General Hospital · 286d
Cleared Feb 11, 2026
SteriHub™ Disinfecting Device and Protective Cover
K251592 · QBP
1World Vista Medical
General Hospital · 264d
Cleared Feb 06, 2026
Stainless Steel Surgical Kits
K251614 · KCT
Dentsply Sirona, Inc.
General Hospital · 255d
Cleared Feb 04, 2026
Henan Yadu Level 4 Surgical Gowns (Reinforced)
K252301 · FYA
Yadu Medical (Henan) Co., Ltd.
General Hospital · 195d
Cleared Jan 30, 2026
Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113,...
K250983 · SCL
Asistan Medikal
General Hospital · 305d
Cleared Jan 29, 2026
UV Smart D60
K251354 · SCS
UV Smart Technologies B.V.
General Hospital · 274d
Cleared Jan 28, 2026
FreedomEdge Infusion System
K252015 · FRN
Koru Medical Systems, Inc.
General Hospital · 215d
Cleared Jan 28, 2026
Sterilization Pouch/Roll
K251347 · FRG
Sterivic Medical Co., Ltd.
General Hospital · 273d
Cleared Jan 23, 2026
Syntex Exam Gloves
K253160 · LZA
Basic Medical Technology, Inc.
General Hospital · 119d
Cleared Jan 22, 2026
Getinge GSS67N Series Steam Sterilizer
K252307 · FLE
Maquet GmbH (A Getinge Group Company)
General Hospital · 182d
Cleared Jan 15, 2026
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
K251308 · LBI
Thera B Medical Products
General Hospital · 262d
Cleared Jan 14, 2026
Cardinal Health Nitrile Examination Gloves Extended Cuff
K252313 · LZC
Cardinalhealth
General Hospital · 173d
Cleared Jan 13, 2026
Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green),...
K252549 · LZA
Kossan International Sdn Bhd
General Hospital · 153d
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