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
164305–164328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 1981
TRIAXIAL
K802348 · JDB
Johnson & Johnson Professionals, Inc.
Orthopedic · 151d
Cleared Feb 23, 1981
INSPIRON PULMONARY FUNCTION ANALYZER
K802920 · BZC
C.R. Bard, Inc.
Anesthesiology · 97d
Cleared Feb 23, 1981
PACING SYSTEM ANALYZER
K803313 · DTE
Medtronic Vascular
Cardiovascular · 54d
Cleared Feb 23, 1981
UNIFOCAL 3
K810121 · DXY
American Pacemaker Corp.
Radiology · 35d
Cleared Feb 23, 1981
VISIO-BAND
K810265 · KLE
Espe-Premier Sales Co.
Dental · 21d
Cleared Feb 23, 1981
ETCHING GEL
K810266 · EJK
Espe-Premier Sales Co.
Dental · 21d
Cleared Feb 23, 1981
DENTURE CLEANER
K810279 · EFT
Mcdennan Oral Products, Inc.
Dental · 21d
Cleared Feb 23, 1981
SURGIKOS FACE MASK
K810316 · FXX
Surgikos, Inc.
General Hospital · 17d
Cleared Feb 23, 1981
CM 3
K810348 · CBP
Instrumentation Industries, Inc.
Anesthesiology · 13d
Cleared Feb 23, 1981
RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE
K810351 · CDP
Endocrine-Metabolic Center
Chemistry · 13d
Cleared Feb 23, 1981
HARRIS CEMENT RESTRICTOR
K810353 · LZN
Cintor Orthopaedic Div.
Orthopedic · 13d
Cleared Feb 23, 1981
PERCUSS-O-FLEX FOOT & HAND MASSAGER
K810354 · ISA
Modern Reflexology, Inc.
Physical Medicine · 13d
Cleared Feb 23, 1981
ALT (UV) TEST
K810355 · CKA
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Feb 23, 1981
BICARBONATE TEST
K810356 · KHS
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Feb 23, 1981
AST (UV) TEST
K810390 · CIT
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Feb 19, 1981
VARIAN V3500 PHASED ARRAY ULTRASONOGRAPH
K802434 · IYO
Varian Assoc., Inc.
Radiology · 136d
Cleared Feb 19, 1981
CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY
K802894 · FJI
Cordis Corp.
Gastroenterology & Urology · 94d
Cleared Feb 19, 1981
BRIGHAM TOTAL ANKLE PROSTHESIS
K803167 · HSN
Howmedica Corp.
Orthopedic · 66d
Cleared Feb 19, 1981
DISPOSABLE DIAPHRAGM DOME
K810009 · DRS
Medex, Inc.
Cardiovascular · 45d
Cleared Feb 19, 1981
LS1000 ELECTRONIC FOCUS
K810118 · IYN
Philips Medical Systems (Cleveland),...
Radiology · 34d
Cleared Feb 19, 1981
MODEL #53110 DISPOSABLE ANOSCOPE
K810227 · FER
Welch Allyn, Inc.
Chemistry · 23d
Cleared Feb 19, 1981
PORTABLE, BATTERY OPERATED DEFIBRILLATOR
K810237 · LDD
Honeywell, Inc.
Cardiovascular · 22d
Cleared Feb 19, 1981
CLINIGUARD STERILE
K810240 · KMF
Clinipad Corp.
General & Plastic Surgery · 22d
Cleared Feb 19, 1981
1.5` FOCAL SPOT RESOLUTION PATTERN
K810254 · IXF
Machlett Laboratories, Inc.
Radiology · 20d