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
148825–148848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 1985
RMC ASPIRATOR - VACUUM PUMP
K850704
Reliance Medical Corp.
General & Plastic Surgery · 92d
Cleared May 24, 1985
OB-PH - PH TEST PAPER
K850858 · LNW
Uro Pharmaceuticals, Inc.
Chemistry · 84d
Cleared May 24, 1985
RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI
K851282 · DEB
Cooper Biomedical, Inc.
Immunology · 53d
Cleared May 24, 1985
RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN
K851287 · DDG
Cooper Biomedical, Inc.
Immunology · 53d
Cleared May 24, 1985
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE
K851923 · CKA
Amresco, Inc.
Chemistry · 22d
Cleared May 24, 1985
TDX REA IRON/TIBC
K851930 · JMO
Abbott Laboratories
Chemistry · 22d
Cleared May 24, 1985
VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM
K851945 · KZR
Varian Assoc., Inc.
Chemistry · 21d
Cleared May 24, 1985
LKB-WALLAC 1230 ARCUS FLUOROMETER
K851984 · KHO
Lkb Instruments, Inc.
Chemistry · 17d
Cleared May 23, 1985
TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-
K843539 · EFN
Molnlycke A/S Hospital Products
Dental · 258d
Cleared May 23, 1985
RENAFLO HEMOCONCENTRATOR
K844790 · KDI
Renal Systems, Inc.
Gastroenterology & Urology · 164d
Cleared May 23, 1985
TRANSPORT INCUBATOR 185
K850496 · FPL
Airborne Life Support Systems, Inc.
General Hospital · 104d
Cleared May 23, 1985
DISPOSABLE UROSTOMY POUCH
K850750 · EXB
Biolog, Inc.
Gastroenterology & Urology · 87d
Cleared May 23, 1985
DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY
K850751 · EXB
Biolog, Inc.
Gastroenterology & Urology · 87d
Cleared May 23, 1985
COMPUTER INTERFACE - BIOFEEDBACK
K850759 · HCC
M.O.E Electronics Research & Prod.
Neurology · 87d
Cleared May 23, 1985
MICRON ONE PORTA. ULTRASONIC NEBULIZER
K850926 · CCQ
Endotek Development Laboratories
Anesthesiology · 79d
Cleared May 23, 1985
OLYMPUS LF-1 INTUBATION SCOPE
K850978 · CAL
Olympus Corp.
Anesthesiology · 76d
Cleared May 23, 1985
PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE
K851024 · CAC
Pfizer, Inc.
Anesthesiology · 72d
Cleared May 23, 1985
NEW VITAJET
K851029 · KZE
Andrew V. Stadler
General Hospital · 72d
Cleared May 23, 1985
RHINOMANOMETERS NR3, NR4
K851143 · BXQ
And/Or Corp.
Anesthesiology · 63d
Cleared May 23, 1985
DIGITAL THERMOMETER
K851146 · FLL
Micro Idea Instrument Co., Ltd.
General Hospital · 63d
Cleared May 23, 1985
AUTORANGING DIGITAL CLINICAL THERMOMETER
K851147 · FLL
Micro Idea Instrument Co., Ltd.
General Hospital · 63d
Cleared May 23, 1985
METACHROME
K851174 · LNJ
Potomac Medical System
Hematology · 59d
Cleared May 23, 1985
ELECTRO-NERVE STIMULATOR B4/B400
K851185 · GZJ
Biomedical Life Systems, Inc.
Neurology · 83d
Cleared May 23, 1985
RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN
K851283 · DDB
Cooper Biomedical, Inc.
Immunology · 52d