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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
148993–149016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1985
COPAL DIGITAL SPHYGMOMANOMETER UA-535
K843390 · DXN
Takeda Medical, Inc.
Cardiovascular · 259d
Cleared May 15, 1985
LABMASTER & CRSI 600
K843435 · FRF
Control Resource Systems, Inc.
General Hospital · 253d
Cleared May 15, 1985
DIGITAL SPHYGMOMANOMETER BP-2500
K843446 · DXN
Pollenex Associated Mills, Inc.
Cardiovascular · 252d
Cleared May 15, 1985
OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA
K844849 · BSZ
Ohmeda Medical
Anesthesiology · 153d
Cleared May 15, 1985
VITALOG PMS-8
K845051 · DPZ
Vitalog Corp.
Anesthesiology · 147d
Cleared May 15, 1985
MARC MEDICAL PROBE COVER-200
K850424 · FLL
K&M Plastics
General Hospital · 100d
Cleared May 15, 1985
PROGRAMALITH III 240 PULSE GENERATOR
K850464 · DXY
Pacesetter Systems
Cardiovascular · 97d
Cleared May 15, 1985
LOGIKAL LONTOPHORESIS UNIT -ANESTHESIA INOTOPHORES
K850508 · EGJ
Kal Life Systems
Physical Medicine · 96d
Cleared May 15, 1985
PEPSODENT DENTURE ADHESIVE CREAM
K850610 · EBD
Lever Brothers Company, Inc.
Dental · 89d
Cleared May 15, 1985
LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS
K850638 · MSJ
Behring Diagnostics, Inc.
Chemistry · 85d
Cleared May 15, 1985
LX120 TISSUE PROCESSOR
K851054 · IEO
Innovative Medical Systems, Inc.
Pathology · 62d
Cleared May 15, 1985
TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/
K851105 · EMG
The Huxley Instrument Corp.
Dental · 57d
Cleared May 15, 1985
R-1000 ECG RECEIVER
K851123 · DXH
Brentwood Instruments, Inc.
Cardiovascular · 57d
Cleared May 15, 1985
T-1000 ECG TRANSMITTER
K851124 · DXH
Brentwood Instruments, Inc.
Cardiovascular · 57d
Cleared May 15, 1985
THUMPER CARDIOPULMONARY RESUSCITATOR 1005
K851139 · DRM
Michigan Instruments, Inc.
Cardiovascular · 55d
Cleared May 15, 1985
ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY
K851245 · BZE
Applinc
Anesthesiology · 49d
Cleared May 15, 1985
OHMEDA MODEL 0001/0003 RECORDER
K851274 · DSF
Ohmeda Medical
Cardiovascular · 44d
Cleared May 15, 1985
ACTION PAC
K851276 · LDQ
South Mountain Medical
General & Plastic Surgery · 44d
Cleared May 15, 1985
QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR
K851302 · DRG
Quinton, Inc.
Cardiovascular · 44d
Cleared May 15, 1985
502 RESUSCITATORY INHALATOR VALVE
K851337 · BTL
Life Support Products, Inc.
Anesthesiology · 42d
Cleared May 15, 1985
ANTINUCLEAR ANTIBODY TEST KIT
K851369 · DHN
Modern Diagnostics, Inc.
Immunology · 40d
Cleared May 15, 1985
SANDER'S MASKCPAP BY RESPIRONICS
K851396 · BYE
Respironics, Inc.
Anesthesiology · 36d
Cleared May 15, 1985
CRCM-30 MEDIUM PRODUCT NO. C5030
K851604 · KIT
Sigma Chemical Co.
Pathology · 29d
Cleared May 15, 1985
SWIN'S S-77 MEDIUM, PRODUCTS S2513
K851605 · KIT
Sigma Chemical Co.
Pathology · 29d