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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
100105–100128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 1995
HEARTHWATCH III(TM)
K945476 · DXH
Instromedix, Inc.
Cardiovascular · 366d
Cleared Nov 09, 1995
TENS-IT, FITTRONIC II, (MORE LATER)
K946018 · GZL
Ems, Inc.
Neurology · 335d
Cleared Nov 09, 1995
NEUROREADER
K950986 · HCS
Artronics
Neurology · 251d
Cleared Nov 09, 1995
IMMUCHEM GAL-MW EA
K951329 · JIA
Icn Pharmaceuticals, Inc.
Chemistry · 231d
Cleared Nov 09, 1995
QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER
K951681 · LNH
Fonar Corp.
Radiology · 212d
Cleared Nov 09, 1995
BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY
K952478 · MMI
Boehringer Mannheim Corp.
Chemistry · 163d
Cleared Nov 09, 1995
ORGEN TEC ANTI-DSDNA ELISA ASSAY
K953671 · LRM
Orgentec
Immunology · 94d
Cleared Nov 09, 1995
CODMAN ANTERIOR CERVICAL PLATE SYSTEM
K953730 · KWQ
Johnson & Johnson Professionals, Inc.
Orthopedic · 91d
Cleared Nov 09, 1995
5 LPM OXYGEN CONCENTRATOR
K953815 · CAW
Devilbiss Health Care, Inc.
Anesthesiology · 87d
Cleared Nov 09, 1995
SAFE-T-SEAL
K953829 · KCT
Gs Medical Packaging, Inc.
General Hospital · 85d
Cleared Nov 09, 1995
DUO BALLOON SYSTEM (DBS) 2 [10 AND 12 MM SIZES]
K954174 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 65d
Cleared Nov 09, 1995
DUO BALLOON SYSTEM (DBS) 1[10 AND 12 MM SIZES]
K954175 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 65d
Cleared Nov 09, 1995
BUONAFEDE PNEUMATIC SLEEVE
K954201 · KCY
Promedic, Inc.
General & Plastic Surgery · 64d
Cleared Nov 09, 1995
MAS LIQUID URINALYSIS CONTROL
K954323 · JJY
Medical Analysis Systems, Inc.
Chemistry · 55d
Cleared Nov 09, 1995
FMS DUO
K954465 · HRX
Future Medical Systems, Inc.
Orthopedic · 45d
Cleared Nov 09, 1995
ABL SYSTEM 625, 615, 605
K954612 · CHL
Radiometer America, Inc.
Chemistry · 35d
Cleared Nov 09, 1995
EXAMINATION PAD
K955094 · IYO
Inventive Products, Inc.
Radiology · 2d
Cleared Nov 08, 1995
PESSARY FLEXIBLE SILICONE NICHOLS
K920633 · KXP
Bioteque America, Inc.
Obstetrics & Gynecology · 1365d
Cleared Nov 08, 1995
ARTHROSCOPE
K942029 · HRX
Surgical Technologies, Inc.
Orthopedic · 561d
Cleared Nov 08, 1995
FIRST CHOICE(TM) TEST STRIP
K946166 · CGA
Polymer Technology Intl.
Chemistry · 324d
Cleared Nov 08, 1995
KIMONO MICROTHIN
K946374 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 329d
Cleared Nov 08, 1995
FIRST CHOICE TEST STRIP
K950628 · CGA
Polymer Technology Intl.
Chemistry · 268d
Cleared Nov 08, 1995
CARDIO-SYSTEMS PRO-OP
K953196 · FNM
Ch Administration, Inc.
General Hospital · 125d
Cleared Nov 08, 1995
SCREW IMPLANTS, GRADE 3
K953234 · DZE
The Implant Center of the Palm Beaches
Dental · 120d