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
112369–112392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1993
PRIZM HEARING SYSTEM
K930909 · ESD
Audioscience, Inc.
Ear, Nose, Throat · 180d
Cleared Aug 09, 1993
FOLEY CATHETER TRAY
K931013 · KNY
Kit Pak, Inc.
Gastroenterology & Urology · 164d
Cleared Aug 09, 1993
SUNGLASSES
K931525 · HQY
Premiums Promotions & Imports, Inc.
Ophthalmic · 136d
Cleared Aug 09, 1993
TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II
K932127 · LGS
Abbott Laboratories
Hematology · 98d
Cleared Aug 09, 1993
SYMBIOSIS DISPOS PULMON BIOPSY FORCEPS W/REUS HAND
K932265 · FCL
Symbiosis Corp.
Gastroenterology & Urology · 111d
Cleared Aug 09, 1993
VENTANA RED DETECTION KIT
K932386 · DEY
Ventana Medical Systems, Inc.
Immunology · 84d
Cleared Aug 09, 1993
FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL
K932459 · ELW
3M Company
Dental · 80d
Cleared Aug 09, 1993
MEDCHEM SURGICAL DELIVERY SYSTEM
K932466 · GCJ
Medco Products, Co., Inc.
General & Plastic Surgery · 80d
Cleared Aug 09, 1993
ACCUTEX IM LATEX TEST
K932551 · KTN
J.S. Medical Assoc.
Immunology · 75d
Cleared Aug 09, 1993
ADHESIVE BANDAGES
K932602 · KGX
Aso Corp.
General & Plastic Surgery · 73d
Cleared Aug 09, 1993
ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR
K933279 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 34d
Cleared Aug 09, 1993
SAW BLADE
K933298 · GFA
Omega Surgical Instruments, Inc.
General & Plastic Surgery · 33d
Cleared Aug 07, 1993
ESOPHAGEAL INTUBATION DETECTOR
K930741 · BTR
Wolfe-Carney Medical
Anesthesiology · 176d
Cleared Aug 06, 1993
NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60
K915494 · CCK
Nellcor, Inc.
Anesthesiology · 606d
Cleared Aug 06, 1993
MOBILAIRE V & III PRO2 OXYGEN SENSORS FEATURES
K924818 · CAW
Invacare Corp.
Anesthesiology · 312d
Cleared Aug 06, 1993
DATASCOPE 6000 MONITOR
K926099 · MLC
Datascope Corp.
Cardiovascular · 246d
Cleared Aug 06, 1993
ALTA DRESSING FRAME
K926380 · KMF
Alta Medical Products, Inc.
General & Plastic Surgery · 227d
Cleared Aug 06, 1993
REUSABLE ENDOSCOPIC SCISSORS, GRASPER-MONOPOLAR
K926583 · GCJ
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 322d
Cleared Aug 06, 1993
THOROCOSCOPY SELF-RETAINING RETRACTOR
K926585 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 322d
Cleared Aug 06, 1993
ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET
K930057 · DYB
B.Braun Medical, Inc.
Cardiovascular · 212d
Cleared Aug 06, 1993
SYSTEM III HALO RING
K930153 · JEC
Jerome Medical
Orthopedic · 206d
Cleared Aug 06, 1993
ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP
K930189 · JWH
Dow Corning Wright
Orthopedic · 204d
Cleared Aug 06, 1993
REAMER BIT
K930339 · HTW
Neoligaments, Ltd.
Orthopedic · 193d
Cleared Aug 06, 1993
TC2000 POWER UNIT AND ACCESSORIES
K930345 · DWJ
Gaymar Industries, Inc.
Cardiovascular · 193d