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
5089–5112 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 29, 2009
SRI LEVEL II SURGICAL GOWN
K090383 · FYA
Sri Surgical
General Hospital · 101d
Cleared May 29, 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER...
K082957 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 238d
Cleared May 27, 2009
PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501
K091097 · FYA
Promedical Products Co., Ltd.
General Hospital · 41d
Cleared May 27, 2009
EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER
K082858 · FQH
Alcavis International, Inc.
General Hospital · 240d
Cleared May 22, 2009
C-PORT - HP POWER INJECTABLE PORT
K091099 · LJT
Phs Medical GmbH
General Hospital · 36d
Cleared May 22, 2009
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K083514 · FMF
Terumo Europe N.V.
General Hospital · 177d
Cleared May 21, 2009
PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M
K082817 · FLE
Primus Sterilizer Company, LLC
General Hospital · 238d
Cleared May 20, 2009
POWER INFUSER, MODEL M100B-3A
K090736 · FRN
ZOLL Medical Corporation
General Hospital · 62d
Cleared May 18, 2009
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE)
K090520 · LYZ
Shandong Huayue Glove Co., Ltd.
General Hospital · 81d
Cleared May 15, 2009
BRAVO AUTOCLAVE, MODELS 17, 17V AND 21V
K090265 · FLE
Scican , Ltd.
General Hospital · 101d
Cleared May 15, 2009
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN...
K090066 · KGO
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 126d
Cleared May 15, 2009
INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022
K083851 · LHI
Inviro Medical Devices, Inc.
General Hospital · 142d
Cleared May 13, 2009
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1
K091040 · FLL
Microlife Intellectual Property GmbH
General Hospital · 30d
Cleared May 12, 2009
NMI PICC
K091261 · LJS
Navilyst Medical, Inc.
General Hospital · 13d
Cleared May 12, 2009
CRONO S-PID 50
K091042 · FRN
Cane S.R.L.
General Hospital · 29d
Cleared May 08, 2009
VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)
K090513 · LYZ
Shandong Huayue Glove Co., Ltd.
General Hospital · 71d
Cleared May 08, 2009
NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K083156 · LZA
Giga-Drive Sdn, Bhd
General Hospital · 196d
Cleared May 07, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K090691 · LYZ
Shijiazhuang Benestar Plastic Co., Ltd.
General Hospital · 52d
Cleared May 05, 2009
CONMED AER DEFENSE SMOKE EVACUATOR
K091139 · FYD
Conmed Corporation
General Hospital · 15d
Cleared May 04, 2009
ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M
K090157 · MMK
Wcm Waste & Compliance Management, Inc.
General Hospital · 102d
Cleared May 01, 2009
TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
K090973 · FOZ
Terumo Corp.
General Hospital · 25d
Cleared May 01, 2009
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION...
K090371 · KCT
STERIS Corporation
General Hospital · 77d
Cleared May 01, 2009
FLOWPICC CATHETER
K083920 · LJS
Vasonova, Inc.
General Hospital · 121d
Cleared May 01, 2009
KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600
K082554 · FRG
Kimberly-Clark Corp.
General Hospital · 240d