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
138841–138864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1987
SEAMED MODEL 3200
K872551 · DTE
Seamed Corp.
Cardiovascular · 32d
Cleared Jul 31, 1987
IMACK-MB(TM)
K872592 · JHT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 30d
Cleared Jul 31, 1987
SOLOS EYESITE CANNULAS
K872610 · HMX
Solos Ophthalmology
Ophthalmic · 25d
Cleared Jul 31, 1987
SOLOS EYESITE SPONGES
K872612 · HOZ
Solos Ophthalmology
Ophthalmic · 25d
Cleared Jul 31, 1987
SOLOS EYESITE DRAPES
K872620 · HMT
Solos Ophthalmology
General Hospital · 25d
Cleared Jul 31, 1987
CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE
K872716 · JGS
Ciba Corning Diagnostics Corp.
Chemistry · 21d
Cleared Jul 31, 1987
THEATRE GOWNS
K872758 · FYA
Smith & Nephew, Inc.
General Hospital · 18d
Cleared Jul 31, 1987
WATERS M600E MULTI-SOLVENT DELIVERY SYSTEM
K872792
Millipore Corp.
Chemistry · 17d
Cleared Jul 31, 1987
ASPEN ESMARK BANDAGE
K872868 · FQM
Aspen Laboratories, Inc.
General Hospital · 10d
Cleared Jul 31, 1987
TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA.
K872897 · JLW
Serono Diagnostics, Inc.
Chemistry · 8d
Cleared Jul 30, 1987
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT
K870817 · LJT
C.R. Bard, Inc.
General Hospital · 149d
Cleared Jul 30, 1987
RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.
K871795 · LQF
Gen-Probe, Inc.
Microbiology · 84d
Cleared Jul 30, 1987
TOXOPLASMA GONDII IGG ELISA
K871905 · LGD
Electro-Nucleonics Laboratories, Inc.
Microbiology · 76d
Cleared Jul 30, 1987
CORTICAL BONE SCREWS
K872738 · HWC
Military Engineering, Inc.
Orthopedic · 20d
Cleared Jul 30, 1987
SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION
K872739 · KIC
D.A. Schulman, Inc.
Physical Medicine · 21d
Cleared Jul 29, 1987
VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200)
K871418 · DXN
Critikon Company, LLC
Cardiovascular · 112d
Cleared Jul 29, 1987
MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER
K871720 · DSK
A&D Engineering, Inc.
Cardiovascular · 86d
Cleared Jul 29, 1987
MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT
K871886 · DXN
Draeger Medical, Inc.
Cardiovascular · 76d
Cleared Jul 29, 1987
MODIFIED DIGITAL BLOOD PRESSURE/PULSE METER
K872144 · DXQ
Vestra-Subco, Inc.
Cardiovascular · 55d
Cleared Jul 29, 1987
TB METHYLENE BLUE
K872184 · JTS
Remel Co.
Pathology · 51d
Cleared Jul 29, 1987
LIGHT GREEN
K872185 · JTS
Remel Co.
Pathology · 51d
Cleared Jul 29, 1987
SULFURIC ACID 10%
K872186 · JTS
Remel Co.
Pathology · 51d
Cleared Jul 29, 1987
TB KINYOUN CARBOLFUCHSIN
K872187 · JTS
Remel Co.
Pathology · 51d
Cleared Jul 29, 1987
METHANOL, ABSOLUTE
K872189 · JTS
Remel Co.
Pathology · 51d