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
11329–11352 of 17,808
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 07, 1994
PATIENT EXAMINATION GLOVE
K934942 · LYY
P.T. Surya Milani Plastic Utama
General Hospital · 84d
Cleared Jan 05, 1994
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S
K932095 · LJT
Pharmacia Deltec, Inc.
General Hospital · 250d
Cleared Jan 05, 1994
PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM
K932840 · LJT
Pharmacia Deltec, Inc.
General Hospital · 208d
Cleared Jan 05, 1994
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS
K932841 · LJT
Pharmacia Deltec, Inc.
General Hospital · 208d
Cleared Dec 30, 1993
STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM
K933884 · LJS
Strato Medical Corp.
General Hospital · 142d
Cleared Dec 29, 1993
BEECH PROLOK
K933732 · FPA
Beech Medical, Inc.
General Hospital · 149d
Cleared Dec 29, 1993
BEECH VERSA LOK
K933749 · FPA
Beech Medical Products, Inc.
General Hospital · 148d
Cleared Dec 29, 1993
PRO-LOK EXTENSION SET
K933852 · FPA
Beech Medical Products, Inc.
General Hospital · 145d
Cleared Dec 22, 1993
POWDER-FREE LATEX EXAMINATION GLOVES
K924906 · LYY
Jentera Jaya Sdn Bhd
General Hospital · 449d
Cleared Dec 22, 1993
ROYAL SHIELD SHIELD GLOVES
K926132 · LYY
Shield Gloves Manufacturer Sdn. Bhd....
General Hospital · 380d
Cleared Dec 22, 1993
HEPA 2500 AIR CLEANER
K930860 · FRF
Trion, Inc.
General Hospital · 307d
Cleared Dec 22, 1993
ENCORE POWDER-FREE SURGICAL GLOVES ORTHOPAEDIA
K932664 · KGO
Smith & Nephew Perry
General Hospital · 203d
Cleared Dec 22, 1993
ENCORE POWDER-FREE SURGICAL GLOVES MICROPTIC
K932665 · KGO
Smith & Nephew Perry
General Hospital · 203d
Cleared Dec 22, 1993
GH GLOVES (POWERED)
K934047 · LYY
Grafik Hersteller Sdn Bhd
General Hospital · 125d
Cleared Dec 22, 1993
GH GLOVES (POWDER FREE)
K934048 · LYY
Grafik Hersteller Sdn Bhd
General Hospital · 125d
Cleared Dec 21, 1993
IN-LINE BURETTE SET
K931658 · FPA
Douglas Medical Products Corp.
General Hospital · 260d
Cleared Dec 21, 1993
STAGE IV, CM-4000,MATTRESS OVERLAY SYSTEM
K933091 · FNM
Creative Medical, Inc.
General Hospital · 180d
Cleared Dec 16, 1993
STERILIZATION WRAP-STERISHEET
K931202 · FRG
Arjo Wiggins Medical, Inc.
General Hospital · 282d
Cleared Dec 14, 1993
KAWASUMI LABORATORIES K-CUFF
K930012 · KZD
Kawasumi Laboratories Co., Ltd.
General Hospital · 344d
Cleared Dec 14, 1993
HUBER NEEDLE INFUSION SET
K932638 · FPA
Douglas Medical Products Corp.
General Hospital · 195d
Cleared Dec 14, 1993
CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
K933050 · FOZ
Critikon Company, LLC
General Hospital · 208d
Cleared Dec 13, 1993
STRATO MEDICAL SINGLE LUMEN VALVED CATHETER
K924851 · LJS
Strato Medical Corp.
General Hospital · 441d
Cleared Dec 13, 1993
FEVER MONITORING KIT
K931747 · FLL
Polymedica Healthcare, Inc.
General Hospital · 249d
Cleared Dec 13, 1993
LACERATION TRAY
K932036 · FRG
Clinipad Corp.
General Hospital · 230d