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
101713–101736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 1995
MODEL 410SI-64 SHOULDER LOOP PAIR, SMALL & LARGEM NIDEK 410SI-42A SHOULDER...
K950966 · MOS
Medical Advances, Inc.
Radiology · 146d
Cleared Jul 26, 1995
MORE CHAIN POWDER FREE VINYL EXAMINATION GLOVES
K951007 · LYZ
Allerderm Laboratories, Inc.
General Hospital · 148d
Cleared Jul 26, 1995
5.8MM DIAMETER ANCHOR SCREW
K951308 · MNH
Advanced Spine Fixation Systems, Inc.
Orthopedic · 126d
Cleared Jul 26, 1995
IMZ - DENTAL IMPLANT
K951610 · DZE
Imz, GmbH
Dental · 110d
Cleared Jul 26, 1995
IMZ - DENTAL IMPLANT COMPONENTS
K951612 · DZE
Imz, GmbH
Dental · 110d
Cleared Jul 26, 1995
IMZ - DENTAL IMPLANT
K951614 · DZE
Imz, GmbH
Dental · 110d
Cleared Jul 26, 1995
IMZ - DENTAL IMPLANT COMPONENTS
K951615 · DZE
Imz, GmbH
Dental · 110d
Cleared Jul 26, 1995
IMZ - DENTAL IMPLANT CASTABLE CSR ATTACHMENT
K951617 · DZE
Imz, GmbH
Dental · 110d
Cleared Jul 26, 1995
IMZ - DENTAL IMPLANT O-RING ATTACHMENT
K951618 · DZE
Imz, GmbH
Dental · 110d
Cleared Jul 26, 1995
ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM
K951624 · HRX
Argus Medical Co., Inc.
Orthopedic · 110d
Cleared Jul 26, 1995
MICRO TITANIUM PLATE SYSTEM
K951688 · JEY
Medicon EG
Dental · 112d
Cleared Jul 26, 1995
TITANIUM MINIPLATE SYSTEM
K951690 · JEY
Medicon EG
Dental · 112d
Cleared Jul 26, 1995
CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM
K951691 · JEY
Medicon EG
Dental · 112d
Cleared Jul 26, 1995
KARL STORZ DRILL
K952008 · GEY
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 89d
Cleared Jul 26, 1995
ROBOCAP
K952025 · JQW
Pharmacia, Inc.
Chemistry · 86d
Cleared Jul 26, 1995
NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES &...
K952070 · KNF
American Hydro-Surgical Instruments,...
Obstetrics & Gynecology · 85d
Cleared Jul 26, 1995
ERGOMAT 8000 SYSTEM
K952092 · FNM
Ergo-Air, Inc.
General Hospital · 84d
Cleared Jul 26, 1995
ERGOMAT 5000 SYSTEM
K952093 · FNM
Ergo-Air, Inc.
General Hospital · 84d
Cleared Jul 26, 1995
EXTENSION SET/I.V. SET
K952243 · FPK
Coast Medical, Inc.
General Hospital · 75d
Cleared Jul 26, 1995
BURNSHIELD TRAUMA DRESSING
K952247 · MGQ
Golightly International Corp.
General & Plastic Surgery · 76d
Cleared Jul 26, 1995
AMERLITE TBG ASSAY
K952284 · CEE
Johnson & Johnson Clinical...
Chemistry · 71d
Cleared Jul 26, 1995
AMUCHINA
K952302 · LRJ
Amuchina Intl., Inc.
General Hospital · 71d
Cleared Jul 26, 1995
STERIGAUZE GEL DRESSING
K952419 · MGQ
Acacia Laboratories, Inc.
General & Plastic Surgery · 64d
Cleared Jul 26, 1995
TECNOL TRANSPARENT WOUND DRESSING
K952504 · MGP
Tecnol Medical Products, Inc.
General & Plastic Surgery · 57d