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
8449–8472 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 21, 1999
HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
K991513 · FPA
I-Flow Corp.
General Hospital · 52d
Cleared Jun 21, 1999
NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER...
K991742 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 31d
Cleared Jun 16, 1999
TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER
K991406 · FOZ
Terumo Medical Corp.
General Hospital · 55d
Cleared Jun 15, 1999
CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD...
K990949 · CAH
Intersurgical, Inc.
General Hospital · 85d
Cleared Jun 15, 1999
DAHEDI INSULIN INFUSION PUMP
K991376 · LZG
Disetronic Medical Systems
General Hospital · 55d
Cleared Jun 15, 1999
CADD ADMINISTRATION SET
K991599 · FPA
Sims Deltec, Inc.
General Hospital · 36d
Cleared Jun 15, 1999
MODIFICATION OF: STERRAD BI TEST PACK
K991675 · FRC
Advanced Sterilization Products
General Hospital · 29d
Cleared Jun 14, 1999
K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE...
K984576 · FMI
Terumo Europe N.V.
General Hospital · 173d
Cleared Jun 14, 1999
MONOJECT INSULIN SYRINGE
K991758 · FMF
The Kendal Co.
General Hospital · 21d
Cleared Jun 11, 1999
LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR...
K991686 · LYY
Arista Latindo Industrial Ltd. P.T
General Hospital · 25d
Cleared Jun 10, 1999
STERI-PAK LF BOWIE-DICK TEST PACK
K990246 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 135d
Cleared Jun 10, 1999
BROWNE MVI ETHYLENE OXIDE INDICATOR
K991418 · JOJ
Albert Browne , Ltd.
General Hospital · 48d
Cleared Jun 09, 1999
CADD-TPN ADMINISTRATION SET, MODEL 21-7071
K991255 · FPA
Sims Deltec, Inc.
General Hospital · 57d
Cleared Jun 09, 1999
CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON...
K991301 · FPA
Sims Deltec, Inc.
General Hospital · 54d
Cleared Jun 08, 1999
MINIMED 508 INSULIN PUMP
K990801 · LZG
Medtronic Minimed
General Hospital · 90d
Cleared Jun 03, 1999
A P HARNESS
K981860 · KMK
Paraworks Enterprise, Ltd.
General Hospital · 372d
Cleared Jun 03, 1999
POWDER FREE BLUE NITRILE GLOVE
K990668 · LZA
Tg Medical Sdn. Bhd.
General Hospital · 93d
Cleared Jun 03, 1999
AUTODOSE INFUSION SYSTEM
K990889 · MEB
Tandem Medical, Inc.
General Hospital · 78d
Cleared Jun 03, 1999
STERIS SMOKE EVACUATION SYSTEM
K991167 · FYD
STERIS Corporation
General Hospital · 57d
Cleared Jun 03, 1999
POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
K991511 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 34d
Cleared Jun 03, 1999
SOFTINJECT
K991680 · KZH
Androsystems Srl
General Hospital · 17d
Cleared May 28, 1999
SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE
K990488 · LYY
Terang Nusa Sdn Bhd
General Hospital · 101d
Cleared May 28, 1999
LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL,...
K991158 · LYY
P. T. Tata Rubberindo Industries
General Hospital · 51d
Cleared May 28, 1999
QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED
K991462 · LYY
Latexx Partners Bhd.
General Hospital · 31d