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
85249–85272 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 1999
PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)
K990261 · LZO
Plus Orthopedics
Orthopedic · 212d
Cleared Aug 27, 1999
CERSR ELECTROMYOGRAPHY SYSTEM
K990766 · IKN
Paraspinal Diagnostic Corp.
Neurology · 172d
Cleared Aug 27, 1999
TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC...
K990785 · GCJ
Jakoubek Medizintechnik GmbH
General & Plastic Surgery · 171d
Cleared Aug 27, 1999
LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
K990903 · GEX
Laserscope
General & Plastic Surgery · 162d
Cleared Aug 27, 1999
OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM
K991055 · MNH
Howmedica Osteonics Corp.
Orthopedic · 150d
Cleared Aug 27, 1999
SYNTHES CERVIFIX SYSTEM
K991089 · KWP
Synthes Spine
Orthopedic · 149d
Cleared Aug 27, 1999
DYNA-LOK PLUS SPINAL SYSTEM
K991198 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 141d
Cleared Aug 27, 1999
KANGNIAN BRAND ACUPUNCTURE NEEDLE
K991507 · MQX
Helio Medical Supplies, Inc.
General Hospital · 120d
Cleared Aug 27, 1999
ACUMASTER BRAND ACUPUNCTURE NEEDLE
K991508 · MQX
Helio Medical Supplies, Inc.
General Hospital · 120d
Cleared Aug 27, 1999
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12...
K991726 · GTZ
Binax, Inc.
Microbiology · 99d
Cleared Aug 27, 1999
FERRIS POLYOSTOMY STERILE WOUND DRESSING
K991729 · KMF
Ferris Mfg. Corp.
General & Plastic Surgery · 99d
Cleared Aug 27, 1999
MITAKA POINT SETTER
K991989 · GWG
Mitaka USA, Inc.
Neurology · 74d
Cleared Aug 27, 1999
SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
K991995 · MZD
Softchrome, Inc.
Ophthalmic · 74d
Cleared Aug 27, 1999
SUPER PORCELAIN TI-22
K992024 · EIH
Noritake Co., Inc.
Dental · 72d
Cleared Aug 27, 1999
BELLEGLAZE
K992067 · EBD
Kerr Dental Materials Center
Dental · 70d
Cleared Aug 27, 1999
TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE
K992071 · HDC
Ron-Tech Medical , Ltd.
Obstetrics & Gynecology · 70d
Cleared Aug 27, 1999
URETHANE PICC LINE MODEL UPICS-
K992198 · FOZ
Cook, Inc.
General Hospital · 58d
Cleared Aug 27, 1999
LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC...
K992236 · EBZ
Lysta A/S
Dental · 56d
Cleared Aug 27, 1999
ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
K992283 · OLV
Airsep Corp.
Neurology · 51d
Cleared Aug 27, 1999
NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX
K992304 · HAW
Image-Guided Neurologics, Inc.
Neurology · 50d
Cleared Aug 27, 1999
SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION
K992457 · HAW
Surgical Navigation Specialists, Inc.
Neurology · 35d
Cleared Aug 27, 1999
MONOPOLAR ELECTRODES AND CABLES
K992485 · GEI
Us Endo, Inc.
General & Plastic Surgery · 32d
Cleared Aug 27, 1999
DYRACT SEAL COMPOMER PIT & FISSURE SEALANT
K992516 · EBC
Dentsply Intl.
Dental · 30d
Cleared Aug 27, 1999
ANATOMICAL BANKART TACK, MODEL 523520A
K992567 · MAI
Bionx Implants, Ltd.
Orthopedic · 25d