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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
73633–73656 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 2002
NEWCOR
K020440 · DQK
Siemens Medical Systems, Inc.
Cardiovascular · 295d
Cleared Dec 03, 2002
DAUM-LECTRIC MRI DRILLING MACHINE
K021098 · ERL
Mri Devices Daum GmbH
Ear, Nose, Throat · 243d
Cleared Dec 03, 2002
ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA...
K022176 · DCK
Orion Diagnostica, Div. Orion Corp.
Immunology · 153d
Cleared Dec 03, 2002
IMTEC SENDAX MDI ORTHO6 AND ORTHO8
K023067 · DZE
Imtec Corp.
Dental · 78d
Cleared Dec 03, 2002
STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE
K023108 · FMF
Atlantic Products, Inc.
General Hospital · 76d
Cleared Dec 03, 2002
T-WAVE ALTERMANS (TWA) ALGORITHM OPTION
K023380 · DQK
General Electric Medical Systems...
Cardiovascular · 56d
Cleared Dec 03, 2002
MODIFICATION TO ENVOY PATIENT MONITOR
K023798 · DSI
Mennen Medical , Ltd.
Cardiovascular · 19d
Cleared Dec 02, 2002
ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M
K020130 · IPF
Rolor Electronics Corp.
Physical Medicine · 321d
Cleared Dec 02, 2002
EXEL VACULET BLOOD COLLECTION SET
K020533 · FPA
Exelint Intl. Co.
General Hospital · 286d
Cleared Dec 02, 2002
MOTEX LATEX EXAMINATION GLOVES, POWDER-FREE
K020837 · LYY
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 263d
Cleared Dec 02, 2002
SANIDAD TENS-DUO MODE GP8016N
K021430 · GZJ
Rolor Electronics Corp.
Neurology · 213d
Cleared Dec 02, 2002
V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT
K021501 · OMP
Kinetic Concepts, Inc.
General & Plastic Surgery · 207d
Cleared Dec 02, 2002
WRIST IMPLANT
K021859 · JWJ
Avanta Orthopaedics, Inc.
Orthopedic · 179d
Cleared Dec 02, 2002
HOME CARE JELLY
K022494 · GYB
Roc Chinese-European Industrial...
Neurology · 126d
Cleared Dec 02, 2002
J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT
K022518 · INI
Roc Chinese-European Industrial...
Physical Medicine · 125d
Cleared Dec 02, 2002
SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA...
K022640 · MCW
Bacchus Vascular, Inc.
Cardiovascular · 116d
Cleared Dec 02, 2002
SCOOTER MARS SERIES, MODEL TL-588
K022698 · INI
Teh Lin Prosthetic & Orthopaedic, Inc.
Physical Medicine · 111d
Cleared Dec 02, 2002
MODEL AMI1200 C-ARM
K022911 · JAA
Integrity Practice Management, Inc.
Radiology · 90d
Cleared Dec 02, 2002
EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
K022933 · HGX
Evenflo Company, Inc.
Obstetrics & Gynecology · 89d
Cleared Dec 02, 2002
MODULAR HEAD BONE SCREW
K022952 · HWC
Biomet, Inc.
Orthopedic · 88d
Cleared Dec 02, 2002
HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS
K022993 · ITI
Hoveround Corp.
Physical Medicine · 84d
Cleared Dec 02, 2002
COLLATEK HYDROGEL
K022995 · MGQ
Biocore Medical Technologies, Inc.
General & Plastic Surgery · 84d
Cleared Dec 02, 2002
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
K023035 · ELM
Ivoclar Vivadent, Inc.
Dental · 81d
Cleared Dec 02, 2002
SST SALIVA SUPPORTING TABLETS
K023046 · LED
Sinclair Pharmaceuticals, Ltd.
Pathology · 81d