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
122785–122808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K905773 · LIT
Mallinckrodt Medical
Cardiovascular · 34d
Cleared Jan 30, 1991
MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT
K905777 · CEE
Immunotech Corp.
Immunology · 34d
Cleared Jan 30, 1991
DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS
K905829 · CEL
Kamiya Biomedical Co.
Chemistry · 30d
Cleared Jan 30, 1991
SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE
K910075 · DHB
Diagnostic Products Corp.
Immunology · 22d
Cleared Jan 29, 1991
CEROS 80 (HA)
K900136 · LYC
Mathys Corp.
Dental · 384d
Cleared Jan 29, 1991
DEVICE PART NUMBER DPI-1106 IMPLANT
K902928 · DZE
Minimatic Implant Technology
Dental · 210d
Cleared Jan 29, 1991
TITANIUM COC ABUTMENT HEADS FOR IMZ
K904605 · DZE
Implant Support Systems, Inc.
Dental · 111d
Cleared Jan 29, 1991
MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE
K904745 · HGP
Graphic Controls Corp.
Obstetrics & Gynecology · 103d
Cleared Jan 29, 1991
ACOUSTIQ LISTENING DEVICE
K904755 · LZI
Krueger Laboratories
Ear, Nose, Throat · 102d
Cleared Jan 29, 1991
AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*
K904931 · GAR
United States Surgical, A Division of...
General & Plastic Surgery · 90d
Cleared Jan 29, 1991
FETAL MONITORING SPIRAL ELECTRODE
K905130 · HGP
Graphic Controls Corp.
Obstetrics & Gynecology · 75d
Cleared Jan 29, 1991
TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP.
K905761 · EJT
Argen Precious Metals, Inc.
Dental · 33d
Cleared Jan 29, 1991
ARGENCO 52HN
K905811 · EJT
Argen Precious Metals, Inc.
Dental · 32d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM900 PP
K910096 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 240 HF
K910099 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 130 D
K910100 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 130 PP
K910101 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 240 PPL
K910102 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ELECTONE BTE MODEL AM 130 HF
K910103 · ESD
Electone, Inc.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
AM130 AGC-O (BEHIND THE EAR) HEARING AID
K910148 · ESD
Electone, Inc.
Ear, Nose, Throat · 15d
Cleared Jan 28, 1991
MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS
K901853 · NAD
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 279d
Cleared Jan 28, 1991
HALA'TUS 1 OXYGENATOR
K903504 · NFB
The Henry G. Dietz Co., Inc.
Anesthesiology · 178d
Cleared Jan 28, 1991
RAPITEX(R) ASL NEW
K903854 · GTQ
Behring Diagnostics, Inc.
Microbiology · 160d
Cleared Jan 28, 1991
DYNATECH MR4000 MICROPLATE READER
K904567 · JJQ
Dynatech Corp.
Microbiology · 111d