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
96169–96192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1996
BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
K960425 · JDI
Endotec, Inc.
Orthopedic · 248d
Cleared Oct 03, 1996
KARL STORZ MODEL 203020 20 EQUIMAT
K961091 · HIG
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 198d
Cleared Oct 03, 1996
MITEK THREADED ANCHOR (MODIFICATION)
K961094 · MBI
Mitek Products
Orthopedic · 203d
Cleared Oct 03, 1996
TWIST-OFF SCREW
K962233 · HWC
Landos, Inc.
Orthopedic · 114d
Cleared Oct 03, 1996
RESOLUT REGENERATIVE MATERIAL
K962624 · LYC
W.L. Gore & Associates, Inc.
Dental · 90d
Cleared Oct 03, 1996
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
K962639 · DSY
Impra, Inc.
Cardiovascular · 90d
Cleared Oct 03, 1996
HORIZON HIP SYSTEM
K962769 · LPH
Biologically Oriented Prostheses
Orthopedic · 79d
Cleared Oct 03, 1996
IMPLANTECH JEJ PERI-PYRIFORM IMPLANT
K962824 · FZE
Implantech Associates, Inc.
General & Plastic Surgery · 76d
Cleared Oct 02, 1996
STERIMASTER AUTOCLAVE
K944036 · FLE
Scican
General Hospital · 776d
Cleared Oct 02, 1996
EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF...
K953983 · FAS
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 406d
Cleared Oct 02, 1996
DANESHVAR WOUND SUPPORT UNIT
K955827 · DXC
Y. Daneshvar
Cardiovascular · 281d
Cleared Oct 02, 1996
PRESSUREGUARD: SELECTCARE
K960188 · FNM
Span-America Medical Systems, Inc.
General Hospital · 260d
Cleared Oct 02, 1996
EAGLE 3000/3100 PATIENT MONITOR
K960272 · MLD
Marquette Electronics, Inc.
Cardiovascular · 258d
Cleared Oct 02, 1996
EAGLE PATIENT MONITOR
K960418 · DSI
Marquette Electronics, Inc.
Cardiovascular · 247d
Cleared Oct 02, 1996
PHACOSCOPE
K960811 · HQC
Saint John'S Plaza Medical Group
Ophthalmic · 218d
Cleared Oct 02, 1996
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL...
K961000 · DTZ
Terumo Medical Corp.
Cardiovascular · 204d
Cleared Oct 02, 1996
SUPERSTAND STAND-UP WHELLCHAIR
K962278 · IPL
The Standing Co., Inc.
Physical Medicine · 111d
Cleared Oct 02, 1996
PATIENT PROTECTIVE LIMB
K962626 · FMQ
Kenad SG Medical, Inc.
General Hospital · 89d
Cleared Oct 02, 1996
ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)
K962745 · JSN
Prepared Media Laboratory, Inc.
Microbiology · 79d
Cleared Oct 02, 1996
ULTIUM SPINAL PLATING SYSTEM
K962784 · MNH
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 77d
Cleared Oct 02, 1996
NULIFE
K962837 · KGO
Med-Tech Rubber & Engineering Industries
General Hospital · 85d
Cleared Oct 02, 1996
FLEXIFLO POLYG GASTOSTOMY TUBE
K963113 · KNT
Abbott Laboratories
Gastroenterology & Urology · 51d
Cleared Oct 02, 1996
ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMER
K963185 · EHD
Electronic Control Concepts
Radiology · 49d
Cleared Oct 02, 1996
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K963200 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 48d