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
123265–123288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 1990
3M IGG FASTLYME(TM) TEST
K895713 · LSR
3M Company
Microbiology · 445d
Cleared Dec 14, 1990
NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH
K900509 · KOD
Medical Latex Corp.
Gastroenterology & Urology · 315d
Cleared Dec 14, 1990
AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET
K902858 · FPA
3M Avi, Inc.
General Hospital · 168d
Cleared Dec 14, 1990
HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE
K903614 · FLE
Harvard Apparatus, Inc.
General Hospital · 127d
Cleared Dec 14, 1990
CAP-AID
K904107 · FMI
Nda Systems
General Hospital · 99d
Cleared Dec 14, 1990
MODEL GLASE 210 HOLMIUM LASER SYSTEM
K904248 · HGF
Charles L. Rose and Co., Inc.
Obstetrics & Gynecology · 88d
Cleared Dec 14, 1990
KRONNER MANIPUJECTOR
K904473 · HES
Unimar, Inc.
Obstetrics & Gynecology · 74d
Cleared Dec 14, 1990
SUPPORT RING
K904485 · LKY
Numedtec, Inc.
Gastroenterology & Urology · 73d
Cleared Dec 14, 1990
SUPPORT PUMP
K904486 · LKY
Numedtec, Inc.
Gastroenterology & Urology · 73d
Cleared Dec 14, 1990
SAFE SYTE I.V. CATHETER PLACEMENT UNIT
K904648 · FOZ
Deseret Medical, Inc.
General Hospital · 64d
Cleared Dec 14, 1990
MRT 35-A (TM)
K905441 · LNH
Toshiba America Mri, Inc.
Radiology · 80d
Cleared Dec 13, 1990
PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.
K901605 · LXS
Phoenix Laser Systems, Inc.
Ophthalmic · 252d
Cleared Dec 13, 1990
ANGEFLATOR(TM)
K902377 · DXT
Angeion Corp.
Cardiovascular · 197d
Cleared Dec 13, 1990
ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20
K902723 · DTM
Electromedics, Inc.
Cardiovascular · 177d
Cleared Dec 13, 1990
SODIUM CHLORIDE SOLUTION
K903347 · FOZ
Superior Healthcare Group, Inc.
General Hospital · 141d
Cleared Dec 13, 1990
QUALTURE
K903470 · JXA
Future Medical Technologies Intl., Inc.
Microbiology · 134d
Cleared Dec 13, 1990
INTERTECH(TM) HEAT AND MOISTURE EXCHANGER
K903519 · BYD
Intertech Resources, Inc.
Anesthesiology · 132d
Cleared Dec 13, 1990
WRP FOLEYCATH
K903777 · EZL
Wembley Rubber Products (M) Sdn Bhd
Gastroenterology & Urology · 115d
Cleared Dec 13, 1990
NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT
K903995 · GHD
Sigma Chemical Co.
Pathology · 106d
Cleared Dec 13, 1990
PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM
K904144 · IZP
Mallinckrodt Group, Inc.
Radiology · 97d
Cleared Dec 13, 1990
HYDRA VISION UROLOGICAL X-RAY SYSTEM
K904145 · KPR
Mallinckrodt Group, Inc.
Radiology · 97d
Cleared Dec 13, 1990
NEURO VISION RADIOGRAPHIC X-RAY SYSTEM
K904146 · KPR
Mallinckrodt Group, Inc.
Radiology · 97d
Cleared Dec 13, 1990
HUGH YOUNG II UROLOGICAL X-RAY SYSTEM
K904147 · KPR
Mallinckrodt Group, Inc.
Radiology · 97d
Cleared Dec 13, 1990
PATHODX HERPES TYPING
K904167 · GQL
Diagnostic Products Corp.
Microbiology · 93d