FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
101161–101184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1995
UNSCENTED MENSTRAL PAD
K953553 · HHD
Paragon Trade Brands, Inc.
Obstetrics & Gynecology · 91d
Cleared Oct 27, 1995
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K953595 · MOS
GE Medical Systems
Radiology · 88d
Cleared Oct 27, 1995
FORTE
K953614 · IMG
Chattanooga Group, Inc.
Physical Medicine · 85d
Cleared Oct 27, 1995
FORTE ES-400
K953615 · IPF
Chattanooga Group, Inc.
Physical Medicine · 85d
Cleared Oct 27, 1995
DUNA II PENILE PROSTHESIS
K953640 · FAE
Dacomed Corp.
Gastroenterology & Urology · 84d
Cleared Oct 27, 1995
GSI 61 CLINICAL AUDIOMETER
K953684 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 85d
Cleared Oct 27, 1995
PROPHET
K953884 · EWO
Qualitone
Ear, Nose, Throat · 71d
Cleared Oct 27, 1995
REDI-VU SYSTEMS (SEND & RECEIVE)
K954008 · LMD
Jd Technical Services, Inc.
Radiology · 63d
Cleared Oct 27, 1995
MINISCOPE MS-3
K954066 · DPS
Schiller America, Inc.
Cardiovascular · 58d
Cleared Oct 27, 1995
TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT &...
K954517 · ETB
Trebay Medical Corp.
Ear, Nose, Throat · 29d
Cleared Oct 27, 1995
TREBAY TOTAL RECTANGULAR HEAD
K954518 · ETA
Trebay Medical Corp.
Ear, Nose, Throat · 29d
Cleared Oct 27, 1995
EXPLOR-X (AZTEH) HF
K954565 · EAP
Chicago X-Ray Systems, Inc.
Radiology · 25d
Cleared Oct 27, 1995
FEMOSTOP, FEMOSTOP PUMP
K954669 · DXC
Radi Medical Systems AB
Cardiovascular · 17d
Cleared Oct 27, 1995
MICRO-PLANER HANDPIECE
K954715 · ERL
Trebay Medical Corp.
Ear, Nose, Throat · 15d
Cleared Oct 26, 1995
ITP-HVPC GALVANIC STIMULATOR
K943007 · IPF
Innovative Therapy Products, Inc.
Physical Medicine · 533d
Cleared Oct 26, 1995
COMMANDER MARK II HAIR REMOVAL SYSTEM
K943872 · KCX
The Helene Edgar Corp.
General & Plastic Surgery · 444d
Cleared Oct 26, 1995
CRW-1 SYSTEM
K944463 · HAW
Radionics Software Applications, Inc.
Neurology · 409d
Cleared Oct 26, 1995
SNAP TESTING DEVICE
K944524 · MNR
Snap Laboratories, LLC
Anesthesiology · 405d
Cleared Oct 26, 1995
THYMATRON 2000 ELECTROCONVULSIVE SYSTEM
K945120 · QGH
Somatics, Inc.
Neurology · 372d
Cleared Oct 26, 1995
ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4,...
K945549 · DIO
Princeton BioMeditech Corp.
Toxicology · 346d
Cleared Oct 26, 1995
COMAN(R) CU-11 MODEL NUMBER 82-6634
K945585 · GWM
Johnson & Johnson Professionals, Inc.
Neurology · 346d
Cleared Oct 26, 1995
A-V IMPULSE SYSTEM MODEL 6060
K951683 · JOW
Novamedix , Ltd.
Cardiovascular · 198d
Cleared Oct 26, 1995
PODOSPRAY DRILL SYSTEM
K951773 · GEY
Darco Intl., Inc.
General & Plastic Surgery · 192d
Cleared Oct 26, 1995
ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC
K952361 · DIO
Princeton BioMeditech Corp.
Toxicology · 171d