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: Cleared only ×
174,955 results
110353–110376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1994
CALCITEK TORQUE WRENCH SYSTEM
K931440 · DZE
Calcitek, Inc.
Dental · 310d
Cleared Jan 26, 1994
HYDRO-TRED/AIR POWERED TREADMILL
K931723 · BXB
Santa FE Swim Systems
Physical Medicine · 310d
Cleared Jan 26, 1994
INTERMEDICS ORTHOPEDICS REAMERS
K931733 · HTP
Intermedics Orthopedics
Orthopedic · 294d
Cleared Jan 26, 1994
CARAPACE WOUND DRESSING KITS & LACERATION TRAYS
K931758 · LRO
Carapace, Inc.
General & Plastic Surgery · 293d
Cleared Jan 26, 1994
CARAPACE SUTURE REMOVAL TRAYS
K931819 · IRO
Carapace, Inc.
Physical Medicine · 293d
Cleared Jan 26, 1994
PENCIL POINT SPINAL NEEDLE AND TRAY
K932569 · BSP
B. Braun of America, Inc.
Anesthesiology · 244d
Cleared Jan 26, 1994
THE TUCKER SLING
K932636 · FRP
Tucker Designs, Ltd.
General Hospital · 238d
Cleared Jan 26, 1994
IRRIGATION ACCESS CAP
K932856 · FPA
Mcgaw, Inc.
General Hospital · 230d
Cleared Jan 26, 1994
OLYMPIC WARM-LAMP
K932881 · ILY
Olympic Medical Corp.
Physical Medicine · 226d
Cleared Jan 26, 1994
STS 701 TRANSPORT STRETCHER
K933071 · FPO
Wy'East Medical Corp.
General Hospital · 218d
Cleared Jan 26, 1994
MOTORIZED ELECTRIC PARALLEL BARS
K933311 · BXB
Midland Mfg. Co.
Physical Medicine · 203d
Cleared Jan 26, 1994
MAGIC TORQUE GUIDEWIRE
K933334 · DQX
Boston Scientific Corp
Cardiovascular · 202d
Cleared Jan 26, 1994
BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
K933590 · DSY
Baxter Healthcare Corp
Cardiovascular · 184d
Cleared Jan 26, 1994
DISPOSE-A-SHEET
K933636 · KME
Belmac Healthcare Corp.
General Hospital · 183d
Cleared Jan 26, 1994
PERMAGEN UNIVERSAL BONDING RESIN
K933745 · EBH
Bio-Systems Research
Dental · 176d
Cleared Jan 26, 1994
HIGH-Q-BOND
K933766 · EBF
Silmet U.S.A. Corp.
Dental · 176d
Cleared Jan 26, 1994
ACUFLEX DISPOSABLE KNIVES
K933921 · HTS
Acufex Microsurgical, Inc.
Orthopedic · 169d
Cleared Jan 26, 1994
STERILE TRACHEOSTOMY TRAY
K934030 · LRO
Surgipro, Inc.
General & Plastic Surgery · 162d
Cleared Jan 26, 1994
JEDENTAL GLASS IONOMER CEMENT AND LINER
K934073 · EMA
Jedental Co., Inc.
Dental · 159d
Cleared Jan 26, 1994
HYDRO-PROBE
K934157 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 155d
Cleared Jan 26, 1994
5MM CALIBRATED SUCTION CANNULA
K934158 · GCJ
Phx Technologies Corp.
General & Plastic Surgery · 155d
Cleared Jan 26, 1994
BARRIER BONE WAX APPLICATOR
K934260 · LXH
Phillips Pharmaceuticals, Inc.
Orthopedic · 148d
Cleared Jan 26, 1994
KING KRIB
K934298 · FNJ
Noritage, Inc.
General Hospital · 146d
Cleared Jan 26, 1994
OSCILLATING BONE SAW BLADE, 6200 SERIES
K934390 · GFA
Boehringer Laboratories
General & Plastic Surgery · 139d