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
93577–93600 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1997
MORPHEE PLUS ALPHA
K964019 · BZD
Nellcor Puritan Bennett, Inc.
Anesthesiology · 254d
Cleared Jun 18, 1997
SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT
K964373 · DWF
3M Healthcare
Cardiovascular · 229d
Cleared Jun 18, 1997
SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT
K964374 · DWF
3M Healthcare
Cardiovascular · 229d
Cleared Jun 18, 1997
LEGIONELLA ELISA TEST SYSTEM
K970149 · LHL
Zeus Scientific, Inc.
Microbiology · 154d
Cleared Jun 18, 1997
BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL
K970809 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 105d
Cleared Jun 18, 1997
PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS
K971010 · LIT
Cordis Corp.
Cardiovascular · 90d
Cleared Jun 18, 1997
LSF TRIAD TOTAL HIP SYSTEM
K971020 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Jun 18, 1997
UNIVERSAL DRIVE SYSTEM
K971059 · HRX
Linvatec Corp.
Orthopedic · 86d
Cleared Jun 18, 1997
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K971289 · KWP
Osteotech, Inc.
Orthopedic · 72d
Cleared Jun 18, 1997
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR,...
K971573 · LBR
Genzyme Corp.
Chemistry · 49d
Cleared Jun 18, 1997
FOCUS-PV BALLOON DILATATION CATHETER
K971577 · LIT
Cardiovascular Dynamics, Inc.
Cardiovascular · 58d
Cleared Jun 18, 1997
OPUS PROGESTERONE
K971725 · JLS
Behring Diagnostics, Inc.
Chemistry · 40d
Cleared Jun 18, 1997
GRAFT HARVESTING SAWBLADES
K971978 · GFA
Wrightmedicaltechnologyinc
General & Plastic Surgery · 20d
Cleared Jun 18, 1997
QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND...
K972080 · JJY
Consolidated Technologies, Inc.
Chemistry · 15d
Cleared Jun 18, 1997
BOVIE MODEL X15
K972161 · GEI
Maxxim Medical
General & Plastic Surgery · 9d
Cleared Jun 17, 1997
KEY CHAIN EMERGENCY AIRWAY
K962312 · BWC
Ffrench Pocket Emergency Airway, Inc.
Anesthesiology · 365d
Cleared Jun 17, 1997
8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,
K963920 · DSP
Arrow Intl., Inc.
Cardiovascular · 260d
Cleared Jun 17, 1997
ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION)
K964818 · GEX
Laserscope
General & Plastic Surgery · 200d
Cleared Jun 17, 1997
OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
K965041 · BSZ
Ohmeda Medical
Anesthesiology · 182d
Cleared Jun 17, 1997
MICRODL DIARYCARD SPIROMETER
K965042 · BZG
Micro Direct, Inc.
Anesthesiology · 182d
Cleared Jun 17, 1997
DYNABITE HOT GI BIOPSY FORCEPS
K970083 · KGE
Portlyn Corp.
Gastroenterology & Urology · 159d
Cleared Jun 17, 1997
BLOOD FLOW ANALYZER
K970887 · HKY
Paradigm Medical Industries, Inc.
Ophthalmic · 98d
Cleared Jun 17, 1997
PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
K970992 · GEH
Premier Dental Products Co.
General & Plastic Surgery · 90d
Cleared Jun 17, 1997
SOFTSCAN
K971024 · GEX
Sahar Technologies, Inc.
General & Plastic Surgery · 89d