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
93073–93096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 17, 1997
AUDALLION III HEARING SYSTEM
K971031 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 17, 1997
DANAVOX MODELS 163/162 BTE
K971032 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 17, 1997
DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES
K971065 · GEX
Xintec Corporation
General & Plastic Surgery · 85d
Cleared Jun 17, 1997
HEARTPORT ENDOARTERIAL RETURN CANNULA
K971291 · DWF
Heartport, Inc.
Cardiovascular · 71d
Cleared Jun 17, 1997
TINAQUANT RHEUMATOID FACTOR ASSAY
K971379 · DHR
Boehringer Mannheim Corp.
Immunology · 64d
Cleared Jun 17, 1997
COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
K971428 · GGN
Pacific Hemostasis
Hematology · 61d
Cleared Jun 17, 1997
STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
K971439 · HQC
Storz Instrument Co.
Ophthalmic · 60d
Cleared Jun 17, 1997
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
K971449 · GIM
Becton Dickinson Vacutainer Systems
Chemistry · 57d
Cleared Jun 17, 1997
CREA OR CREATININE
K971908 · CGX
Carolina Liquid Chemistries Corp.
Chemistry · 25d