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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,808 results
10969–10992 of 17,808
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 10, 1994
DIAL MEDICAL SUPPLY FISTULA NEEDLE SET
K940441 · FOZ
Dial Medical of Florida, Inc.
General Hospital · 130d
Cleared Jun 10, 1994
MODEL TI500 ISOLETTE INFANT INCUBATOR
K941106 · FPL
Air-Shields, Inc.
General Hospital · 95d
Cleared Jun 09, 1994
ENERGIZED DRUG CONTAINER SYSTEM
K934119 · FPA
Abbott Laboratories
General Hospital · 288d
Cleared Jun 06, 1994
POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC24
K936062 · LYY
Hartalega Sdn Bhd
General Hospital · 168d
Cleared Jun 06, 1994
POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC929
K936063 · LYY
Hartalega Sdn Bhd
General Hospital · 168d
Cleared Jun 03, 1994
BE-SAFE
K935843 · FMI
Mathis-Koolpe, Inc.
General Hospital · 177d
Cleared Jun 03, 1994
KIT,I.V. START
K940035 · LYZ
Mason-Keller Corp.
General Hospital · 150d
Cleared Jun 02, 1994
BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE
K922481 · JOJ
Board of Directors, Albert Browne , Ltd.
General Hospital · 737d
Cleared Jun 02, 1994
WAVICIDE MONITOR STRIPS
K932047 · MED
Serim Research Corp.
General Hospital · 401d
Cleared Jun 02, 1994
NAVIGATOR-MP CATHETER LOCATION INSTRUMENT
K940385 · FOZ
Navion Biomedical Corp.
General Hospital · 127d
Cleared May 27, 1994
UNKNOWN
K941032 · FMF
Gelman Sciences, Inc.
General Hospital · 81d
Cleared May 26, 1994
LPH
K931342 · LRJ
Calgon Vestal Div.
General Hospital · 435d
Cleared May 26, 1994
VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM
K931816 · LRJ
Calgon Vestal Div.
General Hospital · 413d
Cleared May 26, 1994
LATEX PATIENT EXAMINATION GLOVE
K940022 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 143d
Cleared May 26, 1994
MEDSURG STERILE O.R. TOWELS
K940175 · KKX
Medsurg Industries, Inc.
General Hospital · 135d
Cleared May 26, 1994
PATIENT EXAMINATION GLOVES
K940576 · LYY
Vijay Latex Products Private , Ltd.
General Hospital · 107d
Cleared May 26, 1994
1ML LUER-LOK SYRINGE
K941562 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 55d
Cleared May 26, 1994
BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE
K941657 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 51d
Cleared May 24, 1994
HYDRAGOWN
K934664 · FYA
Mallinckrodt Group, Inc.
General Hospital · 238d
Cleared May 23, 1994
SHARPS DISPOSABLE CONTAINERS
K931664 · MMK
Bemis Mfg. Co.
General Hospital · 413d
Cleared May 23, 1994
DISPOSABLE BAG DECANTER
K934179 · KPE
Byron Medical
General Hospital · 270d
Cleared May 23, 1994
3M SURGICAL MASK WITH FACE SHEILD
K940707 · FXX
3M Company
General Hospital · 95d
Cleared May 23, 1994
ORION CENTRAL LINE DRESSING CHANGE TRAY
K941542 · FRG
Regulatory & Marketing Services, Inc.
General Hospital · 54d
Cleared May 23, 1994
ADVANTAGE SYRINGE
K941545 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 54d