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
10633–10656 of 17,808
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 20, 1995
BOLUS DISPENSER
K935811 · FPA
I-Flow Corp.
General Hospital · 414d
Cleared Jan 20, 1995
DYNAMEDICS ASAR
K941083 · FNM
Dynamedics Corporation
General Hospital · 318d
Cleared Jan 20, 1995
V-CATH BREAKAWAY NEEDLE INTRODUCER
K945473 · KZH
Hdc Corp.
General Hospital · 73d
Cleared Jan 19, 1995
NEONATAL RESTRAINT AND COMFORT SYSTEMS
K943017 · FRP
K.Bowmed, Inc.
General Hospital · 209d
Cleared Jan 18, 1995
STERILE EXTRA PROTECION SURGEON'S GLOVES
K922979 · KGO
Ansell Malaysia Sdn Bhd
General Hospital · 940d
Cleared Jan 17, 1995
ELASTYREN(R) SURGICAL GLOVES
K945833 · KGO
Eci Medical Technologies, Inc.
General Hospital · 49d
Cleared Jan 17, 1995
LATEX EXAMINATION GLOVE, PATIENT (POWDER-FREE)
K946155 · LYY
Mala Intertrade Co., Ltd.
General Hospital · 32d
Cleared Jan 13, 1995
VERSASAE PLASTIC CANNULA- 11 GAUGE
K945070 · FPA
Imed Corp.
General Hospital · 91d
Cleared Jan 11, 1995
PISTON SYRINGES
K944757 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 106d
Cleared Jan 11, 1995
ROYALSHIELD NON-STERILE POWDER-FREE
K945031 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 90d
Cleared Jan 11, 1995
TUBING, NONINVASIVE
K945978 · GAZ
Endoscopic Technologies, Inc.
General Hospital · 34d
Cleared Jan 11, 1995
MALA LATEX EXAM GLOVES AND SCAN-SUB
K946154 · LYY
Lowenkamp Intl., Inc.
General Hospital · 26d
Cleared Jan 09, 1995
INSYTE INTRODUCER CATHETER
K942045 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 256d
Cleared Jan 04, 1995
IV CATHETER AND OBTURATOR
K941429 · FOS
Becton Dickinson Vascular Access, Inc.
General Hospital · 286d
Cleared Jan 03, 1995
CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH
K926139 · LJT
Bard Access Systems, Inc.
General Hospital · 757d
Cleared Jan 02, 1995
PATIENT EXAMINATION GLOVE
K933602 · LYY
Kerala Rubber & Reclaims, Ltd.
General Hospital · 524d
Cleared Jan 02, 1995
ASEP PLUS SURGICAL DRAPES
K942294 · KKX
Angelica Uniform
General Hospital · 235d
Cleared Jan 02, 1995
OREX SHOE COVERS
K943034 · FXP
Thantex Specialties, Inc.
General Hospital · 189d
Cleared Jan 02, 1995
PATIENT EXAINATION GLOVES
K945045 · LYY
Phoenix Medical Technology, Inc.
General Hospital · 80d
Cleared Jan 02, 1995
POWDERFREE LATEX EXAMINATION GLOVE
K945247 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 67d
Cleared Dec 29, 1994
STERRAD CHEMICAL INDICATOR TAPE
K945190 · JOJ
Advanced Sterilization Products
General Hospital · 66d
Cleared Dec 29, 1994
TRUJECT
K945284 · FMI
Clive Craig Co.
General Hospital · 59d
Cleared Dec 29, 1994
GUARDIAN II GLOVE
K945577 · LZC
Guardian Group, Inc.
General Hospital · 45d
Cleared Dec 27, 1994
SOFT SOCK
K944240 · FQL
Silipos, Inc.
General Hospital · 117d