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
148273–148296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1985
STOPCOCKS
K851986 · FMG
Transamerica Delaval, Inc.
General Hospital · 16d
Cleared May 22, 1985
AMPCO OPTHALMIC TRAY
K842983 · HOZ
Associated Medical Products Co.
Ophthalmic · 296d
Cleared May 22, 1985
SONOMED TECH OPHTHALMIC B-SCAN B-3000
K844031 · ITX
Sonomed Technology, Inc.
Radiology · 219d
Cleared May 22, 1985
MTA 86
K844592
Madsen Electronics (Canada) , Ltd.
Neurology · 177d
Cleared May 22, 1985
EYE PROCEDURE PACK
K850340 · HOZ
Marwood Medical, Inc.
Ophthalmic · 114d
Cleared May 22, 1985
PMS AMNIOCENTESIS TRAY/KIT
K850632 · HIO
Professional Medical Services
Obstetrics & Gynecology · 92d
Cleared May 22, 1985
DENTAL ACRYLIC POLYMERS
K850650 · EBI
Cole Polymers , Ltd.
Dental · 92d
Cleared May 22, 1985
HPU HEAT PROBE AUTOMATED ELECTROCAUTERY SYSTEM
K851096 · KNS
Olympus Corp.
Gastroenterology & Urology · 64d
Cleared May 22, 1985
CODMAN ARTHROSCOPE
K851229 · HRX
Codman & Shurtleff, Inc.
Orthopedic · 57d
Cleared May 22, 1985
RMC POSTERIOR STABILIZED KNEE SYSTEM
K851231 · JWH
Richards Medical Co., Inc.
Orthopedic · 57d
Cleared May 22, 1985
COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME
K851252 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 56d
Cleared May 22, 1985
LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10
K851290 · HIS
Manexim Multicorp, Ltd.
Obstetrics & Gynecology · 51d
Cleared May 22, 1985
LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30
K851291 · HIS
Manexim Multicorp, Ltd.
Obstetrics & Gynecology · 51d
Cleared May 22, 1985
AUSONICS 150
K851696 · IYO
Ausonics Pty , Ltd.
Radiology · 28d
Cleared May 22, 1985
61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA
K851799 · HDF
Artiberia
Obstetrics & Gynecology · 27d
Cleared May 22, 1985
STAPHAUREX ZL30
K851949 · GTN
Wellcome Diagnostics
Microbiology · 19d
Cleared May 22, 1985
INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI
K852020 · HSB
Warsaw Orthopedic, Inc.
Orthopedic · 14d
Cleared May 22, 1985
FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER
K852026 · HWC
Warsaw Orthopedic, Inc.
Orthopedic · 14d
Cleared May 22, 1985
PLAYTEX SLENDER REG. TAMPONS & DEODORANT TAMPONS
K852063 · HEB
Intl. Playtex, Inc.
Obstetrics & Gynecology · 9d
Cleared May 21, 1985
ACR 2500 CARDIOTOMY RESERVOIR FILTER
K842391 · DTN
Electromedics, Inc.
Cardiovascular · 337d
Cleared May 21, 1985
BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL
K842720 · EJL
Penn-Med Technology, Inc.
Dental · 312d
Cleared May 21, 1985
EVOKED RESPONSE ELECTRICAL STIMULATOR
K843226 · ETN
Nucleus, Ltd.
Ear, Nose, Throat · 278d
Cleared May 21, 1985
BIOGRAM
K843725 · JTN
Giles Scientific, Inc.
Microbiology · 239d
Cleared May 21, 1985
MICROTEK IRRIGATION SYSTEM
K844061 · GBX
Microtek Medical, Inc.
General & Plastic Surgery · 215d