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
111625–111648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 1993
SOM 6VI (SURGICAL OPERATING MICROSCOPE)
K926288 · FSO
Jedmed Instrument Co.
General & Plastic Surgery · 302d
Cleared Oct 12, 1993
SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE
K926453 · KWQ
Synthes (Usa)
Orthopedic · 292d
Cleared Oct 12, 1993
BETASTAR 1131.02 MOBILE OPERATING TABLE
K926525 · FQO
Stierlen-Maquet AG
General & Plastic Surgery · 286d
Cleared Oct 12, 1993
DURHAM
K930926 · FPA
Intl. Medical Consultants
General Hospital · 231d
Cleared Oct 12, 1993
STRYKER STAPLER SYSTEM
K931103 · GDW
Stryker Endoscopy
General & Plastic Surgery · 223d
Cleared Oct 12, 1993
IL TEST GLUCOSE
K931402 · CFR
Instrumentation Laboratory CO
Chemistry · 207d
Cleared Oct 12, 1993
MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP
K931549 · FRN
Y
General Hospital · 197d
Cleared Oct 12, 1993
CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS
K932272 · GEX
Lc Ent.
General & Plastic Surgery · 153d
Cleared Oct 12, 1993
TECH-SWITCH ELECTROSURGICAL PENCIL, REUSABLE
K932518 · GEI
Conmedcorp
General & Plastic Surgery · 140d
Cleared Oct 12, 1993
IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599
K932544 · FRN
Y
General Hospital · 139d
Cleared Oct 12, 1993
QUICK SWITCH LAPAROSCOPIC INSTRUMENTS
K932648 · GCJ
Microline Pentax, Inc.
General & Plastic Surgery · 132d
Cleared Oct 12, 1993
ACCESS FOLATE ASSAY
K932887 · CGN
Beckman Coulter, Inc.
Immunology · 120d
Cleared Oct 12, 1993
ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION
K933051 · KNN
General Components Intl., Inc.
Physical Medicine · 140d
Cleared Oct 12, 1993
HI-LO TREATMENT TABLES
K933119 · INQ
Tri W-G, Inc.
Physical Medicine · 109d
Cleared Oct 12, 1993
GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER
K933144 · FRN
Imed Corp.
General Hospital · 106d
Cleared Oct 12, 1993
A-DEC 2612 ASSISTANT'S CART
K933163 · EIA
A-Dec, Inc.
Dental · 105d
Cleared Oct 12, 1993
A-DEC 3131 DUO WALLMOUNT (WITH INSTRUMENTATION)
K933165 · EIA
A-Dec, Inc.
Dental · 105d
Cleared Oct 12, 1993
A-DEC 3127 ASSISTANT'S WALLMOUNT
K933168 · EIA
A-Dec, Inc.
Dental · 105d
Cleared Oct 12, 1993
CV720-727-000, MICROTIP AND FLUE PAK
K933239 · LFL
Valleylab, Inc.
General & Plastic Surgery · 102d
Cleared Oct 12, 1993
VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM
K933386 · GIM
Bd Becton Dickinson Vacutainer...
Chemistry · 92d
Cleared Oct 12, 1993
ACE(TM) CLIN CHEM SYST W/OPT ION SELECT ELECTR(ISE)
K933862 · JGS
Schiapparelli Biosystems, Inc.
Chemistry · 64d
Cleared Oct 08, 1993
SUOP ELECTRODES FOR EXCISIONAL PROCEDURES
K921386 · HGI
Silver Creek Surgical
Obstetrics & Gynecology · 564d
Cleared Oct 08, 1993
URESIL LAPAROSCOPIC RETRACTOR
K921417 · HET
Uresil Corp.
Obstetrics & Gynecology · 563d
Cleared Oct 08, 1993
4 SURE TM RECTAL TUBE
K921852 · KMO
Boston Pacific Medical, Inc.
General Hospital · 539d