FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93385–93408 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 1997
RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
K971605 · ESD
Resound Corp.
Ear, Nose, Throat · 63d
Cleared Jul 03, 1997
CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971631 · JTN
Oxoid , Ltd.
Microbiology · 62d
Cleared Jul 03, 1997
PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971633 · JTN
Oxoid , Ltd.
Microbiology · 62d
Cleared Jul 03, 1997
AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971635 · JTN
Oxoid , Ltd.
Microbiology · 62d
Cleared Jul 03, 1997
SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES
K971666 · LZA
Sj Medical Products (M) Sdn Bhd
General Hospital · 58d
Cleared Jul 03, 1997
ARGOSY DYNAMEQ
K971699 · ESD
Argosy Electronics
Ear, Nose, Throat · 56d
Cleared Jul 03, 1997
ISOLATE
K971809 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 49d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500
K971826 · LDR
Alexander Mfg. Co.
General Hospital · 48d
Cleared Jul 03, 1997
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
K971834 · JNL
Monobind
Immunology · 45d
Cleared Jul 03, 1997
ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
K971835 · DDC
Monobind
Immunology · 45d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P
K971865 · LDR
Alexander Mfg. Co.
General Hospital · 44d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS61010
K971866 · FLL
Alexander Mfg. Co.
General Hospital · 44d
Cleared Jul 03, 1997
LEVO ACTIVE-EASY LAE
K971873 · IPL
Levo USA
Physical Medicine · 44d
Cleared Jul 03, 1997
PEFECT SHOT
K972019 · EIA
International Imaging Electronics
Dental · 32d
Cleared Jul 03, 1997
STEALTH
K972036 · INI
The Buzzz Corp.
Physical Medicine · 31d
Cleared Jul 03, 1997
PROWLER
K972037 · INI
The Buzzz Corp.
Physical Medicine · 31d
Cleared Jul 03, 1997
INTRUDER
K972038 · INI
The Buzzz Corp.
Physical Medicine · 31d
Cleared Jul 03, 1997
NASAL SEPTAL BUTTON
K972060 · LFB
Boston Medical Products, Inc.
Ear, Nose, Throat · 31d
Cleared Jul 03, 1997
UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82
K972068 · DHB
Pharmacia, Inc.
Immunology · 30d
Cleared Jul 03, 1997
CUSTOM NASAL SPLINT
K972082 · LYA
Boston Medical Products, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212
K972084 · FLN
Alexander Mfg. Co.
General Hospital · 29d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224
K972089 · MRZ
Alexander Mfg. Co.
General Hospital · 29d
Cleared Jul 01, 1997
QA-40M DEFIBRILLATOR TESTER
K963190 · DRL
Metron U.S., Inc.
Cardiovascular · 320d
Cleared Jul 01, 1997
HSV-1 ANTIGEN CONTROL SLIDES
K964874 · GQN
Viral Antigens, Inc.
Microbiology · 208d