FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
105289–105312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1995
4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION
K945495 · EXY
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 93d
Cleared Feb 09, 1995
CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES)
K945603 · IRO
Headwaters, Inc.
Physical Medicine · 86d
Cleared Feb 09, 1995
PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL
K945682 · EGY
Gendex Corp.
Radiology · 80d
Cleared Feb 09, 1995
KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES
K946148 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 55d
Cleared Feb 09, 1995
SUMMIT MECHANICAL WHEELCHAIR
K946195 · IOR
Summit Durable Medical Equipment, Inc.
Physical Medicine · 51d
Cleared Feb 09, 1995
OLYMPUS 5FR SEMI-RIGID SCISSORS FOR OB/GYN
K950036 · HIH
Olympus America, Inc.
Obstetrics & Gynecology · 36d
Cleared Feb 09, 1995
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
K950198 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 22d
Cleared Feb 09, 1995
ARGUS LAPAROSCOPY INSTRUMENT SYSTEM
K950378 · GCJ
Argus Medical Co., Inc.
General & Plastic Surgery · 9d
Cleared Feb 08, 1995
NEUROSEARCH-24 OR NRS-24
K915820 · OLT
Lexicor Medical Technology, Inc.
Neurology · 1136d
Cleared Feb 08, 1995
NEUROSEARCH-4
K920038 · HCC
Lexicor
Neurology · 1129d
Cleared Feb 08, 1995
IMMUCHEM PHE-MW EA
K926106 · JNB
Icn Biomedicals, Inc.
Chemistry · 797d
Cleared Feb 08, 1995
NOVA XM2
K932356 · IZH
Dynarad Corp.
Radiology · 636d
Cleared Feb 08, 1995
APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT
K934381 · JWH
Intermedics Orthopedics
Orthopedic · 518d
Cleared Feb 08, 1995
GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH...
K934523 · IYE
Radionics, Inc.
Radiology · 509d
Cleared Feb 08, 1995
TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II
K940817 · JHF
Abbott Laboratories
Chemistry · 351d
Cleared Feb 08, 1995
LORACARBEF GRAM-NAGATIVE PANELS
K940917 · JWY
Baxter Diagnostics, Inc.
Microbiology · 348d
Cleared Feb 08, 1995
FOUNDATION KNEE AUGMENTATION BLOCKS
K941306 · JWH
Encore Orthopedics, Inc.
Orthopedic · 328d
Cleared Feb 08, 1995
MAGIC EAR, ELAIN
K942107 · ESD
Novaplex, Inc.
Ear, Nose, Throat · 282d
Cleared Feb 08, 1995
MICROBORE EXTENSION SET
K942349 · FPA
Excelsior Medical Corp.
General Hospital · 267d
Cleared Feb 08, 1995
EBI ANTERIOR CERVICAL SPINE SYSTEM
K943694 · KWQ
Electro-Biology, Inc.
Orthopedic · 194d
Cleared Feb 08, 1995
UREA NITROGEN REAGENT
K944250 · CDQ
Olympus Corp of America
Chemistry · 160d
Cleared Feb 08, 1995
STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA
K944372 · JXN
Solarcare, Inc.
Toxicology · 154d
Cleared Feb 08, 1995
SCIMED TRANSENT EX STEERABLE GUIDE WIRE AND ACCESSORIES
K944677 · DQX
Scimed Peripheral Interventions
Cardiovascular · 139d
Cleared Feb 08, 1995
PLUM XL INFUSION PUMP
K944733 · FRN
Abbott Laboratories
General Hospital · 135d