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
100225–100248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1995
PROSTHETICS 4MM
K952992 · DZE
Implant Center of the Palm Beaches
Dental · 130d
Cleared Oct 31, 1995
TP-4 WIDE CYLINDER IMPLANTS
K952994 · DZE
Implant Center of the Palm Beaches
Dental · 130d
Cleared Oct 31, 1995
HA/TP COATED CYLINDER IMPLANT 3.3,4.0
K952996 · DZE
Implant Center of the Palm Beaches
Dental · 130d
Cleared Oct 31, 1995
PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED
K952997 · DZE
Implant Center of the Palm Beaches
Dental · 130d
Cleared Oct 31, 1995
TP SCREW IMPLANT 3.75, 4.0-B5
K952998 · DZE
Implant Center of the Palm Beaches
Dental · 130d
Cleared Oct 31, 1995
UNCOATED SCREW IMPLANT 3.75, 4.0-B5
K952999 · DZE
Implant Center of the Palm Beaches
Dental · 130d
Cleared Oct 31, 1995
WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM
K953000 · DZE
Implant Center of the Palm Beaches
Dental · 130d
Cleared Oct 31, 1995
TP-4K SCREW IMPLANT 3.3, 3.75, 4.0
K953001 · DZE
Implant Center of the Palm Beaches
Dental · 130d
Cleared Oct 31, 1995
LACTOSORB BONE PIN
K953194 · HTY
Biomet, Inc.
Orthopedic · 113d
Cleared Oct 31, 1995
SYNTHES FLEXNAIL
K953334 · HSB
Synthes (Usa)
Orthopedic · 106d
Cleared Oct 31, 1995
HEX-FIX FIELD FIXATOR
K953397 · LXT
Smith & Nephew Richards, Inc.
Orthopedic · 103d
Cleared Oct 31, 1995
EBI X FIX DYNAFIX SYSTEM (DFS)
K953406 · KTT
Electro-Biology, Inc.
Orthopedic · 103d
Cleared Oct 31, 1995
RESTORE, THERMACELLS (HOT PACK I)
K953442 · IMD
Neal Dunning Assoc., Inc.
Physical Medicine · 106d
Cleared Oct 31, 1995
ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS
K953870 · GKN
Medtronic Vascular
Hematology · 75d
Cleared Oct 31, 1995
RE-USABLE MONOPOLAR NEEDLE
K953886 · IKT
Chalgren Enterprises, Inc.
Neurology · 75d
Cleared Oct 31, 1995
RE-USABLE CONCENTRIC NEEDLE
K953887 · IKT
Chalgren Enterprises, Inc.
Neurology · 75d
Cleared Oct 31, 1995
LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM
K953937 · IQA
Apt Technology, Inc.
Physical Medicine · 74d
Cleared Oct 31, 1995
6.5MM SOLID CANCELLOUS BONE SCREW
K954485 · HWC
Ace Medical Co.
Orthopedic · 34d
Cleared Oct 31, 1995
THE REIFF QUANTUM WHEELCHAIR, OR QUANTUM WHEELCHAIRS
K954568 · IOR
Reif Wheelchairs and Accessories, Inc.
Physical Medicine · 29d
Cleared Oct 31, 1995
INTRAMEDULLARY HIP SCREW (MODIFICATION)
K954712 · KTT
Smith & Nephew Richards, Inc.
Orthopedic · 76d
Cleared Oct 30, 1995
NUCLEOTOME L KIT
K942987 · GET
Surgical Dynamics, Inc.
General & Plastic Surgery · 497d
Cleared Oct 30, 1995
DERMIVIEW HYPOALLERGENIC CLEAR TAPE
K944587 · KGX
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 406d
Cleared Oct 30, 1995
SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES)
K951921 · LZA
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 189d
Cleared Oct 30, 1995
SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD)
K952052 · LZA
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 182d