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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121465–121488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 1991
CHAMPION, BEHIND-THE-EAR HEARING AID
K911705 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
MODEL 800, BEHIND-THE-EAR HEARING AID
K911706 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
REGAL, BEHIND-THE-EAR HEARING AID
K911707 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
MODEL E-50, IN-THE-EAR HEARING AID
K911708 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
STOCK CANAL, IN-THE-EAR HEARING AID
K911709 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 16, 1991
XEMEX TEMPORARY PACING CATHETER A
K904868 · LDF
Zeon Medical Corp.
Cardiovascular · 199d
Cleared May 16, 1991
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
K905824 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 136d
Cleared May 16, 1991
RMI VASCULAR TOURNIQUET KIT
K910221 · DXC
Research Medical, Inc.
Cardiovascular · 119d
Cleared May 16, 1991
WARMAIR SYSTEM
K910327 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 111d
Cleared May 16, 1991
CORDIS PEEL-AWAY INSERTION TOOL
K910688 · DYB
Cordis Corp.
Cardiovascular · 86d
Cleared May 16, 1991
MODIFIED PYROGEN TESTING
K910935 · DTM
Electromedics, Inc.
Cardiovascular · 91d
Cleared May 16, 1991
TORQUE DEVICE FOR A GUIDE WIRE
K910969 · DQX
Terumo Corp.
Cardiovascular · 71d
Cleared May 16, 1991
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
K911122 · DXY
Intermedics, Inc.
Cardiovascular · 65d
Cleared May 15, 1991
BIO-VENT-X ENDOSSEOUS HA COATED DENTAL IMPLANTS
K902968 · DZE
Core-Vent Corp.
Dental · 313d
Cleared May 15, 1991
FOUNDATION HYBRID COMPOSITE
K904135 · EBD
Nulite Systems Research
Dental · 251d
Cleared May 15, 1991
MODEL STT-100
K904853 · IYO
Sonocare, Inc.
Radiology · 198d
Cleared May 15, 1991
ADVANTX AFM ANGIO SYSTEM S1808
K905653 · IZI
GE Medical Systems
Radiology · 148d
Cleared May 15, 1991
SONOPAK/QS, SONOPAK
K905657 · NFQ
Bioresearch
Dental · 149d
Cleared May 15, 1991
QDR-1000 AND WITH X-RAY BONE DENSITOMETER
K905691 · KGI
Hologic, Inc.
Radiology · 147d
Cleared May 15, 1991
CLEARVIEW HCG SERUM/URINE
K905741 · JHI
Unipath , Ltd.
Chemistry · 142d
Cleared May 15, 1991
URODYNAMIC MEASURING SYSTEM
K910371 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 106d
Cleared May 15, 1991
NATIVE PROTHROMBIN ANTIGEN EIA
K910617 · DDF
Organon Teknika Corp.
Immunology · 92d
Cleared May 15, 1991
TOTAL BILIRUBIN REAGENT SET
K910635 · CIG
Biochemical Trade, Inc.
Chemistry · 92d
Cleared May 15, 1991
#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES
K910781 · ETF
Midmark Corp.
Ear, Nose, Throat · 79d