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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
84745–84768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 26, 1999
SILVERSTEIN MICROWICK
K991670 · ETD
Micromedics, Inc.
Ear, Nose, Throat · 101d
Cleared Aug 26, 1999
HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
K991841 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 90d
Cleared Aug 26, 1999
THERMOFLEX SYSTEM
K991847 · KNS
Argomed, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 26, 1999
OSTEOPLAST, MODEL POP200
K991854 · MQV
Interpore Cross Intl.
Orthopedic · 86d
Cleared Aug 26, 1999
PASCO MIC AND MIC/ID PANELS
K991925 · JWY
Pasco Laboratories, Inc.
Microbiology · 79d
Cleared Aug 26, 1999
PICCOLO METLYTE 7 REAGENT DISC
K992140 · JLB
Abaxis, Inc.
Chemistry · 63d
Cleared Aug 26, 1999
FLUOROPLASTIC VENTILATION TUBES
K992222 · ETD
Gyrus Ent LLC
Ear, Nose, Throat · 56d
Cleared Aug 26, 1999
HEPARIN CONTROL PLASMA LEVEL 1
K992278 · GGN
Pacific Hemostasis
Hematology · 50d
Cleared Aug 26, 1999
HEPARIN CONTROL PLASMA LEVEL 2
K992279 · GGN
Pacific Hemostasis
Hematology · 50d