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
5977–6000 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 10, 2006
WILLCARE, MODEL GW-1020
K052594 · FRN
Icu Medical, Inc.
General Hospital · 142d
Cleared Feb 09, 2006
SOOTHIES GEL PADS
K052858 · NXH
Puronxy, Inc.
General Hospital · 121d
Cleared Feb 06, 2006
SEJOY, MODEL MT-403
K051699 · FLL
Sejoy Electronics & Instruments Co.,...
General Hospital · 227d
Cleared Feb 02, 2006
GRANTALDER RHAPSODY ACCESS PORT AND CATHETER
K043178 · LJT
Grantadler Corportation
General Hospital · 443d
Cleared Feb 01, 2006
BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE
K053443 · KGO
Regent Medical Americas, LLC
General Hospital · 54d
Cleared Feb 01, 2006
KANGSHENG BRAND/KANGNIAN BRAND/UNILINK BRAND/HUAZHONG BRAND ACUPUNCTURE NEEDLES
K052731 · MQX
Daxin LI
General Hospital · 125d
Cleared Jan 31, 2006
BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER
K060006 · FLL
Braun GmbH
General Hospital · 28d
Cleared Jan 31, 2006
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND...
K053226 · FRN
Zimmer, Inc.
General Hospital · 75d
Cleared Jan 31, 2006
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
K053177 · LZG
Medtronic Minimed
General Hospital · 78d
Cleared Jan 25, 2006
NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR...
K052666 · LYY
Ascend Eagle, Inc.
General Hospital · 120d
Cleared Jan 24, 2006
B. BRAUN 0.2 MICRON FILTER
K052773 · FMF
B.Braun Medical, Inc.
General Hospital · 113d
Cleared Jan 19, 2006
POWDER FREE VINYL EXAMINATION GLOVE
K052985 · LYZ
Tg Medical (China) Incorporation
General Hospital · 87d
Cleared Jan 19, 2006
NITRILE BLUE POWDERED EXAMINATION GLOVES
K052955 · LZA
Great Glove Sdn Bhd
General Hospital · 90d
Cleared Jan 19, 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K052729 · LYZ
Shijiazhuang Brilliant Ocean Plastic...
General Hospital · 112d
Cleared Jan 19, 2006
CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
K042504 · FOZ
Myco Medical Supplies, Inc.
General Hospital · 491d
Cleared Jan 18, 2006
DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE
K053259 · LYZ
Practical Protective Plastic...
General Hospital · 57d
Cleared Jan 17, 2006
PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER
K051566 · FLL
Proton Healthcare , Ltd.
General Hospital · 217d
Cleared Jan 13, 2006
POWERPICC
K053501 · LJS
Bard Access Systems, Inc.
General Hospital · 28d
Cleared Jan 13, 2006
SEVEN STAR NEEDLE
K052723 · MQX
Helio Medical Supplies, Inc.
General Hospital · 106d
Cleared Jan 12, 2006
ALARIS SAFETY MALE LUER
K053049 · FPA
Cardinal Health, Alaris Products
General Hospital · 76d
Cleared Jan 11, 2006
POWDERED VINYL EXAMINATION GLOVE
K052984 · LYZ
Tg Medical (China) Incorporation
General Hospital · 79d
Cleared Jan 10, 2006
TEGO, MODEL D1000
K053106 · FPA
Icu Medical, Inc.
General Hospital · 67d
Cleared Jan 05, 2006
CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES
K053272 · KGO
Cardinalhealth
General Hospital · 43d
Cleared Dec 28, 2005
PROTECTOR NEEDLE SHEATH PROP
K052725 · FMI
Certol International, LLC
General Hospital · 90d