Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
172681–172704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 1978
DINAMAP MODEL 850
K780127 · DRS
Applied Medical Research
Cardiovascular · 7d
Cleared Jan 31, 1978
BLOOD PRESSURE MONITOR, ARTERIAL
K780128 · DRS
Applied Medical Research
Cardiovascular · 7d
Cleared Jan 31, 1978
CEMENT EXTRACTION INSTRUMENT SET
K780135 · KDG
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 7d
Cleared Jan 31, 1978
COLLAR, CERVICAL, SPLIT
K780136 · IQK
Richard'S Medical Equip., Inc.
Physical Medicine · 6d
Cleared Jan 30, 1978
TQC CALIBRATION REFERENCE FOR PLATELETS
K770143 · KRY
Technicon Instruments Corp.
Hematology · 371d
Cleared Jan 30, 1978
TDL-100 B
K772050 · DXY
Pacesetter Systems
Cardiovascular · 91d
Cleared Jan 30, 1978
MDL-201
K772051 · DXY
Pacesetter Systems
Cardiovascular · 91d
Cleared Jan 30, 1978
PACEMAKER, PERM. & TEMP., ELECTRODE
K772197 · DTB
Daig Corp.
Cardiovascular · 66d
Cleared Jan 30, 1978
LENS, HARD RESIN
K772221 · HQG
Borani Intl.
Ophthalmic · 56d
Cleared Jan 30, 1978
PULSE GENERATOR, UNIPOLAR, PROGRAMABLE
K772238 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 53d
Cleared Jan 30, 1978
PULSE GENERATOR, BIPOLAR, PROGRAMMABLE
K772239 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 53d
Cleared Jan 30, 1978
PULSE GENERATOR, UNIPOLAR, DEMAND
K772240 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 53d
Cleared Jan 30, 1978
PULSE GENERATOR, BIPOLAR, DEMAND
K772241 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 53d
Cleared Jan 30, 1978
CATHETER, CHOLANGIOGRAM, OPERATIVE
K772288 · GBZ
Gesco Intl., Inc.
General & Plastic Surgery · 49d
Cleared Jan 30, 1978
X-RAY CO-ORDINATOR
K772313 · IWY
Rinn Corp.
Radiology · 49d
Cleared Jan 30, 1978
ETHYLENE OXIDE STERILI. INDICATOR
K772358 · JOJ
Bio-Medical Sciences, Inc.
General Hospital · 34d
Cleared Jan 30, 1978
LASER IMMUNONEPHELOMETRIC ANALYZER
K772361 · JQX
G.D. Searle and Co.
Chemistry · 34d
Cleared Jan 30, 1978
SPECTACLE FRAME, OP-TITE
K772368 · HQZ
Dentsply Intl.
Ophthalmic · 34d
Cleared Jan 30, 1978
17-HYDROXY TEST
K772426 · CDB
Hycel, Inc.
Chemistry · 34d
Cleared Jan 30, 1978
SERUM GLUTAMIC OXALOACETIC TRANSAMINASE
K780013 · CIT
Macomb Chemical Co.
Chemistry · 27d
Cleared Jan 30, 1978
AUTO. SLIDE STAINER
K780017 · KPA
Honeywell, Inc.
Hematology · 27d
Cleared Jan 30, 1978
CARDIAC PACER, MODEL 208
K780066 · DXY
Cordis Corp.
Cardiovascular · 18d
Cleared Jan 30, 1978
OXYGEN THERAPY KIT
K780084 · CAN
Thermadyne Holings Corp.
Anesthesiology · 14d
Cleared Jan 30, 1978
CANE/REACHER
K780085 · IPS
Fred Sammons, Inc.
Physical Medicine · 14d