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
148753–148776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 1985
NEOS - PULSE GENERATOR
K844812 · DXY
Biotronik Sales, Inc.
Cardiovascular · 128d
Cleared Apr 18, 1985
ND2100 SPINE SCANNER
K844835 · KGI
Nuclear Data, Inc.
Radiology · 127d
Cleared Apr 18, 1985
KALOS-04 PULSE GENERATOR
K844841 · DXY
Biotronik Sales, Inc.
Cardiovascular · 127d
Cleared Apr 18, 1985
NEOS-LP PULSE GENERATOR
K844842 · DXY
Biotronik Sales, Inc.
Cardiovascular · 127d
Cleared Apr 18, 1985
TELEMANOMETER
K850166 · DRG
R.J. Ash, Medical Monitoring, Inc.
Cardiovascular · 92d
Cleared Apr 18, 1985
ULTRASOUND GEL
K850290 · IYO
Litton Datamedix
Radiology · 84d
Cleared Apr 18, 1985
UNISONIC ELECTRONIC DIGITAL BP MONITOR EMB-4050
K850318 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 83d
Cleared Apr 18, 1985
DISPLAY MONITOR (VD-711RA-VD-712RA)
K850343 · DXJ
Nihon Kohden America, Inc.
Cardiovascular · 80d
Cleared Apr 18, 1985
NEONATAL MONITOR 309
K850407 · DRT
Rigel Medical Electronics, Inc.
Cardiovascular · 73d
Cleared Apr 18, 1985
AIM N' SHOOT - AUTOMATIC EXPOSURE CONTROL
K850678 · IZL
Fairchild Medical Systems, Inc.
Radiology · 56d
Cleared Apr 18, 1985
PATIENT MONITOR MODEL RM-300
K850794 · DTR
Honeywell, Inc.
Cardiovascular · 51d
Cleared Apr 18, 1985
SUN BEDS
K851255 · FTC
Tannhut
General & Plastic Surgery · 21d
Cleared Apr 17, 1985
SILICONE SPLINTING MATERIAL
K840113 · MDA
General Dental Products, Inc.
General & Plastic Surgery · 462d
Cleared Apr 17, 1985
H-H TENDEON IMPLANT
K843013
Holter-Hausner Intl.
Orthopedic · 260d
Cleared Apr 17, 1985
ARROW-GEISS PERCUTANEOUS TPN KIT
K844080 · LJS
Arrow Intl., Inc.
General Hospital · 180d
Cleared Apr 17, 1985
ETHICON - CHOLANGIOCLIP
K850273 · FZP
Ethicon, Inc.
General & Plastic Surgery · 84d
Cleared Apr 17, 1985
ESCHWEILER SYSTEM 2000 - GLOOD GAS ANALYZERS
K850360 · CHL
Text Tech Corp.
Chemistry · 77d
Cleared Apr 17, 1985
FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE
K850560 · CAX
Precision Medical, Inc.
Anesthesiology · 64d
Cleared Apr 17, 1985
ALBA DRY BURN PAD
K850881
Alba Health Care
General & Plastic Surgery · 44d
Cleared Apr 17, 1985
ALBA DRY BURN DRESSING
K850904 · NAD
Alba Health Care
General & Plastic Surgery · 43d
Cleared Apr 17, 1985
V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS
K850947 · GAG
American V. Mueller
General & Plastic Surgery · 41d
Cleared Apr 17, 1985
SINGLE LEG MAYFIELD TABLE
K851022
Ohio Medical Instrument Co., Inc.
General & Plastic Surgery · 36d
Cleared Apr 17, 1985
ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870
K851278 · LDP
Stanbio Laboratory
Toxicology · 16d
Cleared Apr 17, 1985
ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S
K851308 · CIX
Technicon Instruments Corp.
Chemistry · 16d