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
92857–92880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 1997
TBD
K965245 · HGI
Utah Medical Products, Inc.
Obstetrics & Gynecology · 184d
Cleared Jul 03, 1997
BIO-ESTHETIC INDIRECT ABUTMENT
K970073 · NHA
Steri-Oss, Inc.
Dental · 176d
Cleared Jul 03, 1997
UNIJECT EXAMINATION GLOVES
K970191 · LYY
Uniject Gloves , Ltd.
General Hospital · 168d
Cleared Jul 03, 1997
NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
K970300 · LPH
Intermedics Orthopedics
Orthopedic · 160d
Cleared Jul 03, 1997
SHARPS CONTAINER
K970383 · FMI
Custom Medical Plastics, Inc.
General Hospital · 150d
Cleared Jul 03, 1997
SHARPS CONTAINER
K970398 · FMI
Custom Medical Plastics, Inc.
General Hospital · 150d
Cleared Jul 03, 1997
ONE STEP MARIJUANA CARD TEST
K970548 · LDJ
Teco Diagnostics
Toxicology · 141d
Cleared Jul 03, 1997
ONE STEP MORPHINE CARD TEST
K970579 · DNK
Teco Diagnostics
Toxicology · 139d
Cleared Jul 03, 1997
BONE & MARROW CLLECTION SYSTEM
K971268 · GEY
Biomedical International Corp.
General & Plastic Surgery · 87d
Cleared Jul 03, 1997
PURE COMPANY FLUID DELIVERY SYSTEM
K971278 · EIA
Pure Co.
Dental · 87d
Cleared Jul 03, 1997
VERSION 4 OPERATING SYSTEM SOFTWARE
K971279 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 87d
Cleared Jul 03, 1997
MEDISURF
K971347 · LMD
International Regulatory Consultants
Radiology · 84d
Cleared Jul 03, 1997
MEDRAD FLEX INTERFACE DEVICE
K971380 · LNH
Medrad, Inc.
Radiology · 80d
Cleared Jul 03, 1997
CORDIS OPTA LP PTA BALLOON CATHETER
K971448 · LIT
Cordis Corp.
Cardiovascular · 73d
Cleared Jul 03, 1997
RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4
K971489 · IZI
Philips Medical Systems North...
Radiology · 71d
Cleared Jul 03, 1997
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
K971605 · ESD
Resound Corp.
Ear, Nose, Throat · 63d
Cleared Jul 03, 1997
CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971631 · JTN
Oxoid , Ltd.
Microbiology · 62d
Cleared Jul 03, 1997
PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971633 · JTN
Oxoid , Ltd.
Microbiology · 62d
Cleared Jul 03, 1997
AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971635 · JTN
Oxoid , Ltd.
Microbiology · 62d
Cleared Jul 03, 1997
SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES
K971666 · LZA
Sj Medical Products (M) Sdn Bhd
General Hospital · 58d
Cleared Jul 03, 1997
ARGOSY DYNAMEQ
K971699 · ESD
Argosy Electronics
Ear, Nose, Throat · 56d
Cleared Jul 03, 1997
ISOLATE
K971809 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 49d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500
K971826 · LDR
Alexander Mfg. Co.
General Hospital · 48d
Cleared Jul 03, 1997
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
K971834 · JNL
Monobind
Immunology · 45d