FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79177–79200 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2001
2.0/2.4 CANNULATED SCREW SYSTEM
K010783 · HWC
Osteomed Corp.
Orthopedic · 76d
Cleared May 30, 2001
PERC-D SPINEWAND
K010811 · HRX
Arthrocare Corp.
Orthopedic · 72d
Cleared May 30, 2001
MARK 9000 PHASED ARRAY SHOULDER COIL
K010946 · MOS
Usa Instruments, Inc.
Radiology · 62d
Cleared May 30, 2001
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
K011002 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 57d
Cleared May 30, 2001
FORTAFLEX SURGICAL SLING
K011027 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 55d
Cleared May 30, 2001
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
K011105 · GAL
Qrc Consulting
General & Plastic Surgery · 49d
Cleared May 30, 2001
MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)
K011111 · KPR
Modular X-Ray Devices
Radiology · 49d
Cleared May 30, 2001
EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM
K011252 · IYO
Hitachi Medical Corp.
Radiology · 36d
Cleared May 30, 2001
PROGNOST ES, MODEL 0302 0000
K011290 · IZF
Xmar Corp.
Radiology · 33d
Cleared May 30, 2001
ALPCO MILENIA ANTI-TG EIA
K011415 · JZO
American Laboratory Products Co., Ltd.
Immunology · 22d
Cleared May 29, 2001
VECTORSURGE 5, MODEL VS-500
K002058 · IPF
Metron Medical Australia, Pty, Ltd.
Physical Medicine · 327d
Cleared May 29, 2001
DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
K003630 · MVA
Danmar Products, Inc.
Neurology · 186d
Cleared May 29, 2001
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
K003647 · DIS
Alfa Scientific Designs, Inc.
Toxicology · 183d
Cleared May 29, 2001
SCS CLOSED SCREW
K003733 · MNH
Ortho Tec, LLC
Orthopedic · 176d
Cleared May 29, 2001
SYNTHES SYNEX SPACER SYSTEM
K003836 · MQP
Synthes
Orthopedic · 168d
Cleared May 29, 2001
MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)
K003845 · LAF
Alfa Scientific Designs, Inc.
Toxicology · 168d
Cleared May 29, 2001
MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)
K003847 · LAF
Alfa Scientific Designs, Inc.
Toxicology · 168d
Cleared May 29, 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP)
K003879 · JXM
Alfa Scientific Designs, Inc.
Toxicology · 165d
Cleared May 29, 2001
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST
K003881 · JXM
Alfa Scientific Designs, Inc.
Toxicology · 165d
Cleared May 29, 2001
INSTANT-VIEW METHADONE URINE DIP STRIP TEST
K010014 · DJR
Alfa Scientific Designs, Inc.
Toxicology · 147d
Cleared May 29, 2001
INSTANT-VIEW METHADONE URINE CASSETTE TEST
K010015 · DJR
Alfa Scientific Designs, Inc.
Toxicology · 147d
Cleared May 29, 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
K010045 · LCM
Alfa Scientific Designs, Inc.
Toxicology · 144d
Cleared May 29, 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST
K010047 · LCM
Alfa Scientific Designs, Inc.
Toxicology · 144d
Cleared May 29, 2001
INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
K010079 · DOE
Alfa Scientific Designs, Inc.
Toxicology · 139d