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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
172249–172272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 1977
HEEL/ELBOW PROTECTOR
K771913 · FMP
Alba-Waldensian, Inc.
General Hospital · 35d
Cleared Nov 15, 1977
HYDRON ROOT CANAL FILLING SYSTEM
K771921 · KIF
National Patent Development Corp.
Dental · 34d
Cleared Nov 15, 1977
CONTINUOUS FLOW ANESTHESIA MACHINE
K771989 · BSZ
Draeger Medical, Inc.
Anesthesiology · 27d
Cleared Nov 15, 1977
TELETHERMOMETER MODEL T T-400
K771997 · FLL
Electromedics, Inc.
Chemistry · 25d
Cleared Nov 15, 1977
TEMP-A-LERT MODEL TA-986
K771998 · FLL
Electromedics, Inc.
Chemistry · 25d
Cleared Nov 15, 1977
ELECTROTHERM MODELS F&C18,14,78, F84
K771999 · FLL
Electromedics, Inc.
Chemistry · 25d
Cleared Nov 15, 1977
PATIENT HEATER SYSTEM, MODEL PH112
K772015 · DWJ
Carolina Medical Electronics
Cardiovascular · 21d
Cleared Nov 15, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH
K772028 · CFJ
Harleco
Chemistry · 19d
Cleared Nov 15, 1977
GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT
K772029 · CIT
Harleco
Chemistry · 19d
Cleared Nov 15, 1977
PENTAX F.O.-IT OBSERVER SCOPE
K772055
Pilling Co.
Ophthalmic · 15d
Cleared Nov 15, 1977
CATHETER, PACING/MONITORING
K772059 · DYG
Electro-Catheter Corp.
Cardiovascular · 15d
Cleared Nov 15, 1977
NEONATAL FLOTATION SYSTEM
K772062 · IKY
Medpro, Inc.
General Hospital · 13d
Cleared Nov 15, 1977
MANIFOLD & NEBULIZER, UNIVERSAL
K772068 · CAF
Inspiron Corp.
Anesthesiology · 14d
Cleared Nov 15, 1977
VOL. VENTILATOR SETUP W/OUT NEBULIZER
K772069 · BZO
Inspiron Corp.
Anesthesiology · 14d
Cleared Nov 15, 1977
VENTILATOR SETUP, VOLUME
K772070 · CAF
Inspiron Corp.
Anesthesiology · 14d
Cleared Nov 15, 1977
MANIFOLD & NEBU. FOR SINGLE LINE MACH.
K772071 · CAF
Inspiron Corp.
Anesthesiology · 14d
Cleared Nov 15, 1977
MANIFOLD & NEBU. FOR DOUB. LINE MACH.
K772072 · CAF
Inspiron Corp.
Anesthesiology · 14d
Cleared Nov 14, 1977
LAS-R CERULOPLASMIN TEST
K771795 · DDB
Hyland Therapeutic Div., Travenol...
Immunology · 52d
Cleared Nov 14, 1977
ACCU-PAQUE
K771886 · EIH
Williams Gold Refining Co., Inc.
Dental · 40d
Cleared Nov 14, 1977
ACCU-STAIN
K771887 · EIH
Williams Gold Refining Co., Inc.
Dental · 40d
Cleared Nov 14, 1977
IRON SET, ITEM NO. 65008
K771927 · JMO
Harleco
Chemistry · 31d
Cleared Nov 14, 1977
CALCIUM SET, ITEM NO. 65004
K771928 · CJY
Harleco
Chemistry · 31d
Cleared Nov 14, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT
K772030 · CKA
Harleco
Chemistry · 18d
Cleared Nov 14, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT
K772031
Harleco
Chemistry · 18d