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
138049–138072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1987
CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY
K874379 · CZY
Cytotech, Inc.
Immunology · 30d
Cleared Nov 25, 1987
IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064
K874406 · DGC
Medix Biotech, Inc.
Immunology · 28d
Cleared Nov 25, 1987
LIVE OAK ALLERGEN DISC
K874440 · DHB
Incstar Corp.
Immunology · 28d
Cleared Nov 25, 1987
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011
K874476 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Nov 25, 1987
MYCO-FLUOR REAGENT A & B
K874662 · JTS
Scott Laboratories, Inc.
Pathology · 12d
Cleared Nov 24, 1987
ELEC-TIP
K873298 · GXY
Etymotic Research
Neurology · 98d
Cleared Nov 24, 1987
TODD MEDICAL/SKILLED CARE PRODUCTS
K873499 · BTO
Todd Medical, Inc.
Anesthesiology · 85d
Cleared Nov 24, 1987
NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY
K873737 · CDP
Cambridge Medical Technology
Chemistry · 70d
Cleared Nov 24, 1987
HUMID-VENT(R) 2 PORT
K873768 · BYD
Gibeck Respiration
Anesthesiology · 69d
Cleared Nov 24, 1987
GLUCOSE-HK REAGENT
K873835 · CFR
Intersect Systems, Inc.
Chemistry · 64d
Cleared Nov 24, 1987
BAXA EXACTA-MED PHARMACY PUMP
K873875 · FRN
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 63d
Cleared Nov 24, 1987
HOT WHEELS
K873895 · ITI
Everest & Jennings, Inc.
Physical Medicine · 61d
Cleared Nov 24, 1987
IRAS GLARE TESTER
K873987 · HLJ
Randwal Instrument Co., Inc.
Ophthalmic · 56d
Cleared Nov 24, 1987
BRACHIAL PLEXUS CATHETER - BP-01200
K874105 · CAZ
Arrow Intl., Inc.
Anesthesiology · 46d
Cleared Nov 24, 1987
TITAN GEL REP LDH-30 HV
K874142 · CFE
Helena Laboratories
Chemistry · 42d
Cleared Nov 24, 1987
TITAN GEL REP LDH-6 HV
K874145 · CFE
Helena Laboratories
Chemistry · 42d
Cleared Nov 24, 1987
ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS
K874295 · BZT
Sheridan Catheter Corp.
Anesthesiology · 35d
Cleared Nov 24, 1987
EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683
K874397 · LBS
Em Diagnostic Systems, Inc.
Chemistry · 27d
Cleared Nov 24, 1987
CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT
K874456 · LIO
Tm & M C/O Burditt,Bowles,Radzius &...
Microbiology · 27d
Cleared Nov 24, 1987
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
K874578 · KLS
Syva Co.
Chemistry · 18d
Cleared Nov 24, 1987
ACE SELFTAPPING CANCELLOUS BONE SCREW
K874593 · HWC
Ace Medical Co.
Orthopedic · 15d
Cleared Nov 23, 1987
PROTEIN STANDARD CALIBRATOR
K871755 · JIX
Wako Chemicals USA, Inc.
Chemistry · 202d
Cleared Nov 23, 1987
VITALOG PMS-8 (MODIFICATION)
K871813 · BZQ
Vitalog Corp.
Anesthesiology · 199d
Cleared Nov 23, 1987
CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/
K871928 · HIF
Medline Industries, Inc.
Obstetrics & Gynecology · 189d