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
101857–101880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1995
ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT
K951850 · LJM
Helix Diagnostics, Inc.
Immunology · 88d
Cleared Jul 18, 1995
POWER RESECTOSCOPE CUTTING LOOP
K951897 · FAS
Power Analytics Corp.
Gastroenterology & Urology · 85d
Cleared Jul 18, 1995
ULTRASOUND TRANSDUCER, MODEL US917
K952031 · HGL
Advanced Medical Systems, Inc.
Obstetrics & Gynecology · 78d
Cleared Jul 18, 1995
ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY
K952055 · LRM
American Laboratory Products Co., Ltd.
Immunology · 77d
Cleared Jul 18, 1995
ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER
K952082 · EXJ
Rochester Medical Corp.
Gastroenterology & Urology · 76d
Cleared Jul 18, 1995
SAS BRUCELLA SUIS ANTIGEN
K952139 · GSO
Sa Scientific, Inc.
Microbiology · 71d
Cleared Jul 18, 1995
SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM
K952145 · GSN
Sa Scientific, Inc.
Microbiology · 71d
Cleared Jul 17, 1995
SPECTRADOP
K925078 · JOP
Bennett and Assoc., Inc.
Cardiovascular · 1013d
Cleared Jul 17, 1995
NEWOX2
K945754 · DQA
Bci Intl., Inc.
Anesthesiology · 236d
Cleared Jul 17, 1995
PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION...
K950178 · LZE
Pharma-Plast Intl. A/S
Orthopedic · 181d
Cleared Jul 17, 1995
OMS SLIMLINE PHACO HANDPIECE
K950218 · HQC
Optical Micro Systems, Inc.
Ophthalmic · 179d
Cleared Jul 17, 1995
DEPUY AMK CO-CR FINNED TIBIAL TRAY
K951027 · JWH
Depuy, Inc.
Orthopedic · 133d
Cleared Jul 17, 1995
ULTIMAX
K951473 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 109d
Cleared Jul 17, 1995
FREDEIC BEAUSOCEIL
K951551 · HQY
Pascal Mathieux
Ophthalmic · 104d
Cleared Jul 17, 1995
CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50)
K951775 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 91d
Cleared Jul 17, 1995
ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT
K951798 · LJM
Helix Diagnostics, Inc.
Immunology · 90d
Cleared Jul 17, 1995
SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]
K951904 · JDO
Synthes (Usa)
Orthopedic · 84d
Cleared Jul 17, 1995
SUNGLASSES
K951979 · HQY
Heyro Optical Manufactory
Ophthalmic · 81d
Cleared Jul 17, 1995
SAS FEBRILE ANTIGEN SET
K952131 · GSO
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS SALMONELLA H D ANTIGEN
K952135 · GSO
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS SALMONELLA H B ANTIGEN
K952136 · GSO
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS SALMONELLA H A ANTIGEN
K952137 · GSO
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS FRANCISELLA TULARENSIS ANTIGEN
K952138 · GSL
Sa Scientific, Inc.
Microbiology · 70d
Cleared Jul 17, 1995
SAS BRUCELLA MELTIENSIS ANTIGEN
K952140 · GSO
Sa Scientific, Inc.
Microbiology · 70d