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
168049–168072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1979
NELATON CATHETER
K792038 · KOD
American Hospital Supply Corp.
Gastroenterology & Urology · 32d
Cleared Nov 13, 1979
BARD BIOMEDICAL PRINTED SILVER ELECTRODE
K792040 · DRX
C.R. Bard, Inc.
Cardiovascular · 32d
Cleared Nov 13, 1979
CKG CARDIOKYMOGRAPH
K792051 · DSB
Cardio Kinetics, Inc.
Cardiovascular · 29d
Cleared Nov 13, 1979
SPECTRA CENTRAL PT MONITORING SYS
K792081 · DSI
American Optical Corp.
Cardiovascular · 28d
Cleared Nov 13, 1979
GAVAGE FEEDING SET
K792082 · EYN
Medical Devices, Inc.
General & Plastic Surgery · 28d
Cleared Nov 13, 1979
MICROFLAME PHOTOMETER
K792087 · JJO
Gilford Instrument Laboratories, Inc.
Chemistry · 27d
Cleared Nov 13, 1979
DRYDEN BACTERIA FILTER
K792097 · CAH
Dryden Corp.
General Hospital · 26d
Cleared Nov 13, 1979
GAS-TRAK BLOOD GAS CONTROL
K792098 · JJS
United Diagnostics, Inc.
Chemistry · 25d
Cleared Nov 13, 1979
GRASPING FORCEP (W/FOUR PRONGS)
K792100 · GEN
Eder Instrument Co, Inc.
General & Plastic Surgery · 25d
Cleared Nov 13, 1979
AIR-SHIELDS HEART RATE MONITOR
K792117 · DRT
Narco Air-Shields
Cardiovascular · 18d
Cleared Nov 13, 1979
AIR-SHIELDS RESUSCITATORS
K792118 · BTM
Narco Air-Shields
Anesthesiology · 18d
Cleared Nov 13, 1979
EMIT CLINICAL PROCESSOR-CP 5000
K792129 · JQP
Syva Co.
Toxicology · 20d
Cleared Nov 13, 1979
TRANSVENOUS BALLOON CATH. INTRO. KIT
K792130 · DYB
Stanco Medical, Inc.
Cardiovascular · 18d
Cleared Nov 13, 1979
TEMPORARY TRANSVENOUS PACMKER. ELECTRODE
K792131 · DYB
Stanco Medical, Inc.
Cardiovascular · 18d
Cleared Nov 13, 1979
SMAC (SEQUENTIAL MULT. ANALYSIS COMP.
K792138 · CEK
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Nov 13, 1979
FEATHER-LITE URINARY DIV. POUCH
K792139 · EXB
Howmedica Corp.
Gastroenterology & Urology · 22d
Cleared Nov 13, 1979
FISHER DIAG. PRIME BLOOD GAS CONTROLS
K792143 · JJS
Fisher Scientific Co., LLC
Chemistry · 20d
Cleared Nov 13, 1979
MTC OXYGEN CONCENTRATOR, OR PRIME-AIRE
K792149 · CAW
Molecular Technologies Corp.
Anesthesiology · 22d
Cleared Nov 13, 1979
OXYGENATOR GAS LINE FILTER
K792151 · KRI
Cardio Systems, Inc.
Cardiovascular · 22d
Cleared Nov 13, 1979
CARDIOPLEGIA SOLUTION ADMIN. SET
K792152 · DWF
Cardio Systems, Inc.
Cardiovascular · 22d
Cleared Nov 13, 1979
DIGOXIN RADIOIMMUNOASSAY SYSTEM
K792153 · DPB
Radioimmunoassay, Inc.
Toxicology · 18d
Cleared Nov 13, 1979
THYROID STIMULATING HORMONE
K792154 · JLW
Radioimmunoassay, Inc.
Chemistry · 19d
Cleared Nov 13, 1979
DENTAL MOUTHPROP (BITE BLOCK)
K792157 · JXL
Mission Dental, Inc.
Neurology · 15d
Cleared Nov 13, 1979
125 I PROLACTIN HORMONE RIA KIT
K792166 · CFT
Diagnostic Products Corp.
Chemistry · 15d