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
4801–4824 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 09, 2010
GRAFT DELIVERY SYSTEM MODEL SA-6115
K100754 · FMF
Micromedics, Inc.
General Hospital · 84d
Cleared Jun 08, 2010
LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE...
K093193 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 238d
Cleared Jun 03, 2010
ULTICARE DISPOSABLE PEN NEEDLES
K100812 · FMI
Ultimed, Inc.
General Hospital · 72d
Cleared Jun 03, 2010
BD INTIMA II CLOSED IV CATHETER
K100775 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 77d
Cleared Jun 02, 2010
GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA
K100563 · FLL
Geon Corporation
General Hospital · 93d
Cleared May 28, 2010
VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED
K093264 · LYZ
Qingdao Lang Hui Import & Export Co.,...
General Hospital · 221d
Cleared May 28, 2010
NON-INVASIVE INFRARED (NIR)
K090386 · FLL
Medisim, Ltd.
General Hospital · 465d
Cleared May 26, 2010
U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118
K100942 · FLL
Taidoc Technology Corporation
General Hospital · 51d
Cleared May 20, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100699 · LYZ
Shijiazhuang Star Plastic Co., Ltd.
General Hospital · 70d
Cleared May 20, 2010
POWDER-FREE NITRILE GLOVES, BLACK
K100369 · LZA
Hl Rubber Industries Sdn Bhd
General Hospital · 97d
Cleared May 20, 2010
ROYAL GUARD
K092617 · LZA
Shun Thai Rubber Gloves Industry...
General Hospital · 267d
Cleared May 19, 2010
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100856 · LYZ
Suzhou Shengyuda Plastic Products...
General Hospital · 54d
Cleared May 18, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100735 · LYZ
Rayu Plastic Products Limited
General Hospital · 64d
Cleared May 18, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100734 · LYZ
Huanfu Plastic Products Limited
General Hospital · 64d
Cleared May 17, 2010
MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1
K100953 · FLL
Microlife Intellectual Property GmbH
General Hospital · 41d
Cleared May 14, 2010
ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION...
K100704 · FRN
Disetronic Medical Systems AG
General Hospital · 63d
Cleared May 14, 2010
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100294 · LYZ
Zibo Yinghao Medical Products Co., Ltd.
General Hospital · 101d
Cleared May 14, 2010
SMART-READ EZTEST-STEAM SCBI AND TEST PACK
K093794 · FRC
Sgm Biotech, Inc.
General Hospital · 155d
Cleared May 13, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100697 · LYZ
Shijiazhuang Universal Channel...
General Hospital · 63d
Cleared May 11, 2010
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH...
K100211 · LYY
Shen Wei (Usa), Inc.
General Hospital · 106d
Cleared May 11, 2010
AESCULAP STERILCONTAINER S
K093649 · FRG
Aesculap
General Hospital · 167d
Cleared May 10, 2010
EPIDRUM
K093863 · FMF
Exmoor Plastics , Ltd.
General Hospital · 144d
Cleared May 10, 2010
ACTIPROTECT UF N95 RESPIRATOR
K093161 · ONT
Glaxosmithkline Consumer Healthcare
General Hospital · 216d
Cleared May 07, 2010
IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6,...
K091336 · LGZ
Enthermics Medical Systems, Inc.
General Hospital · 366d