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
152473–152496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 1984
DRAGER SPHYGMOMED
K840162 · DXN
Draeger Medical, Inc.
Cardiovascular · 138d
Cleared May 30, 1984
POLY PLUG CEMENT RESTRICTOR
K840242 · JDS
Latham Manufacturer
Orthopedic · 131d
Cleared May 30, 1984
HANCOCK PERICARDIAL PATCH
K840262 · DXZ
Extracorporeal Medical Specialities,...
Cardiovascular · 132d
Cleared May 30, 1984
LIFECYCLE AEROBIC MONITOR 123
K840488 · BZQ
Heart Rate, Inc.
Anesthesiology · 114d
Cleared May 30, 1984
EXU-DRY BURN-TRAUMA DRESSING-VARIOUS
K840498
Fraass Survival Systems, Inc.
General & Plastic Surgery · 114d
Cleared May 30, 1984
HEMOPERFUSION SYSTEM TP-400
K840532 · FLD
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 119d
Cleared May 30, 1984
TPN/CVP DRESSING CHANGE KIT
K840620 · FMC
Marwood Medical, Inc.
General Hospital · 106d
Cleared May 30, 1984
ELVI 444 BILITRON
K840757 · CIG
Logos Scientific, Inc.
Chemistry · 97d
Cleared May 30, 1984
PREG BETA BLUS SLIDE
K840833 · JHJ
Intl. Diagnostic, Inc.
Chemistry · 96d
Cleared May 30, 1984
TONSIL KNIFE-VARIOUS
K841005 · KBQ
Premier Dental Products Co.
Ear, Nose, Throat · 82d
Cleared May 30, 1984
EAR KNIFE-VARIOUS
K841006 · JYO
Premier Dental Products Co.
Ear, Nose, Throat · 82d
Cleared May 30, 1984
VENTILATOR EXTERNAL BODY NEGATIVE PRESS
K841090 · BYT
Porta-Lung Co.
Anesthesiology · 78d
Cleared May 30, 1984
MEDICAL CHAIR, MULTIPURPOSE TAST SUPPORT
K841194 · INM
Neutral Pos-Chair Co.
Physical Medicine · 70d
Cleared May 30, 1984
PRIMA 236-02 NONPROGRAMMABLE CARDIAC
K841404 · DXY
Intermedics, Inc.
Cardiovascular · 57d
Cleared May 30, 1984
MAXI-MISER HUMIDIFIER INSERT 1020
K841569
Nova-Ventrx
Cardiovascular · 43d
Cleared May 30, 1984
MAXI-MISER WATER TRANSFER SET 1021/1022
K841571
Nova-Ventrx
Cardiovascular · 43d
Cleared May 30, 1984
ELECTRONIC MUSCLE EXERCISE EQUIPMENT
K841779 · IPF
Bloomex International, Inc.
Physical Medicine · 30d
Cleared May 30, 1984
TRIGLYCERIDE ASSAY KIT-COLORIMETRIC
K842157
Diagnostic Chemicals, Ltd. (Usa)
Chemistry
Cleared May 29, 1984
EAR CURETTE, VARIOUS
K841001 · JYG
Premier Dental Products Co.
Ear, Nose, Throat · 81d
Cleared May 25, 1984
NEURO SECTOR FIXATION DEVICE
K833522 · GXW
Advanced Technology Laboratories, Inc.
Neurology · 249d
Cleared May 25, 1984
P-S MEDICAL CSF ACCESS DEV 15MM/25MM
K833822 · LKG
Pudenz-Schulte Medical Research Corp.
General Hospital · 205d
Cleared May 25, 1984
LITHOTRIPTOR ELECTRODE 4.5F
K834228 · FFK
Monaghan Medical Corp.
Gastroenterology & Urology · 171d
Cleared May 25, 1984
AMNIO STAT-FLM AGGLUTINATION TEST
K834616 · JHG
Hana Biologics, Inc.
Microbiology · 163d
Cleared May 25, 1984
SHEER ENERGY PANTY HOSE
K840335 · DWL
Leggs Products, Inc.
General Hospital · 121d