FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,766 results
11185–11208 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 16, 1994
CLAVE VIAL ACCESS SPIKE
K934591 · FMI
Icu Medical, Inc.
General Hospital · 145d
Cleared Feb 15, 1994
WILTEK IRRIGAITON/ASPIRATION TUBE SET
K922989 · BYY
Wiltek Medical, Inc.
General Hospital · 603d
Cleared Feb 15, 1994
EXTRACORPOREAL TEMPERATURE SENSOR
K935603 · FLL
Smiths Industries Medical Systems, Inc.
General Hospital · 89d
Cleared Feb 15, 1994
O.R. BASIN SET TRAY
K935741 · LRO
Cush Medical Products
General Hospital · 76d
Cleared Feb 14, 1994
ONCO-VIAL ADAPTER
K926071 · LHI
David Bull Laboratories, USA, Inc.
General Hospital · 440d
Cleared Feb 14, 1994
PROCEL(TM) DERMALINER GLOVE
K931094 · LYU
W.L. Gore & Associates, Inc.
General Hospital · 348d
Cleared Feb 14, 1994
GERITREX STERILE WATER FOR IRRIGATION
K931511 · JOL
Geritrex Corp.
General Hospital · 325d
Cleared Feb 14, 1994
LIFESHIELD BLOOD COLLECTION DEVICE
K933751 · FMI
Sherwood Medical Co.
General Hospital · 195d
Cleared Feb 10, 1994
BARRIER EXTRA PROTECTION PLUS FACE MASK
K920108 · FXX
Johnson & Johnson Medical, Inc.
General Hospital · 762d
Cleared Feb 10, 1994
3M PREVENTION FABRIC SURGICAL GOWN #78XX
K930681 · FYA
3M Health Care, Ltd.
General Hospital · 365d
Cleared Feb 10, 1994
SKYTRON EXAM LIGHT
K933564 · KZF
Skytron, Div. the Kmw Group, Inc.
General Hospital · 203d
Cleared Feb 10, 1994
ONE TIME VIAL ACCESS SPIKE
K934561 · FMF
Icu Medical, Inc.
General Hospital · 142d
Cleared Feb 10, 1994
VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER
K935514 · FMI
Kawasumi Laboratories Co., Ltd.
General Hospital · 86d
Cleared Feb 10, 1994
INCISION/DRAINAGE TRAY
K935681 · FRG
Cush Medical Products
General Hospital · 73d
Cleared Feb 10, 1994
LACERATION TRAY
K935682 · FRG
Cush Medical Products
General Hospital · 73d
Cleared Feb 10, 1994
SUTURE REMOVAL TRAY
K935683 · FRG
Cush Medical Products
General Hospital · 73d
Cleared Feb 10, 1994
TRACHEOSTOMY CARE TRAY
K935685 · FRG
Cush Medical Products
General Hospital · 73d
Cleared Feb 10, 1994
SKIN SCRUB TRAY
K935742 · FRG
Cush Medical Products
General Hospital · 71d
Cleared Feb 09, 1994
MEDIJECT DISPOSABLE SYRINGES
K920039 · FMF
P.T. Igar Jaya
General Hospital · 765d
Cleared Feb 09, 1994
MODEL 561 C-ARM PROCEDURES STRETCHER
K923730 · FPO
Midmark Corp.
General Hospital · 562d
Cleared Feb 09, 1994
ACU-EVAC
K930043 · FYD
Acuderm, Inc.
General Hospital · 400d
Cleared Feb 09, 1994
LATEX EXAMINATION GLOVES
K930655 · LYY
Pushpaman Processors, Div. Kanjur...
General Hospital · 365d
Cleared Feb 09, 1994
THEREX LOW-PROFILE PORT .6MM I.D 2.3MM O.D.
K932447 · LJT
Therex Corp.
General Hospital · 265d
Cleared Feb 09, 1994
MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES
K933294 · FPB
Aesculap, Inc.
General Hospital · 217d