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
152689–152712 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 1984
ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS
K841991 · CCQ
Armour Pharmaceutical Co.
Anesthesiology · 79d
Cleared Jul 27, 1984
MIDAS II AUTOMATIC STAINER
K842077 · KPA
Innovative Medical Systems, Inc.
Hematology · 65d
Cleared Jul 27, 1984
TECHNICON TEST POINT ASSAYED HEMATOLOGY
K842109 · JPK
Technicon Instruments Corp.
Hematology · 59d
Cleared Jul 27, 1984
HISTOPAQUE-1077
K842146 · JCF
Sigma Chemical Co.
Hematology · 58d
Cleared Jul 27, 1984
COULTER AUTOMATIC SAMPLE HANDLER
K842346 · GKL
Coulter Electronics, Inc.
Hematology · 43d
Cleared Jul 27, 1984
ECHO PULSE BURST
K842414 · GZJ
Rabar, Inc.
Neurology · 38d
Cleared Jul 27, 1984
SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH
K842440 · JPK
Anco Medical Reagents & Assoc.
Microbiology · 36d
Cleared Jul 27, 1984
B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS
K842579 · JTR
Biological & Environmental Control...
Microbiology · 24d
Cleared Jul 27, 1984
SIRC
K842583 · KIR
Viromed Laboratories, Inc.
Pathology · 24d
Cleared Jul 27, 1984
HEK
K842584 · KIR
Viromed Laboratories, Inc.
Pathology · 24d
Cleared Jul 27, 1984
RESPIRONICS VENT EASY OXYGEN ENRICHME
K842605 · CAE
Respironics, Inc.
Anesthesiology · 22d
Cleared Jul 27, 1984
TECHNICON H*1 SYSTEM
K842636 · GKZ
Technicon Instruments Corp.
Hematology · 18d
Cleared Jul 27, 1984
LIFE-MASK INFANT RESUSCITATOR
K842696 · BTM
Electronic Monitors, Inc.
Anesthesiology · 16d
Cleared Jul 27, 1984
CODMAN SUCTION PUNCH-PRODUCT CODES
K842774 · HTZ
Codman & Shurtleff, Inc.
General & Plastic Surgery · 11d
Cleared Jul 27, 1984
DRYDEN SCAVENGER INTERFACE SYSTEM
K842843
Dryden Corp.
Cardiovascular · 7d
Cleared Jul 26, 1984
SALIVARY BYPASS TUBE
K841350
E. Benson Hood Laboratories, Inc.
Gastroenterology & Urology · 115d
Cleared Jul 26, 1984
E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS
K841720 · LJE
E-Z-Em, Inc.
Gastroenterology & Urology · 92d
Cleared Jul 26, 1984
INFANT NASAL CANNULAE ASSEMBLY
K841773 · BZD
Ackrad Laboratories
Anesthesiology · 87d
Cleared Jul 26, 1984
SECHRIST AIR-OXYGEN MIXER & ANCILLARY
K841789 · BZR
Shiley, Inc.
Anesthesiology · 87d
Cleared Jul 26, 1984
UNCUFFED REINFORCED TRACHEAL TUBE
K841872 · BTR
Mallinckrodt Critical Care
Anesthesiology · 80d
Cleared Jul 26, 1984
LFT - 212
K841879 · LIL
Medical Monitoring Systems, Inc.
Gastroenterology & Urology · 80d
Cleared Jul 26, 1984
ENTERAL FEEDING BOTTLE
K841945 · KNT
Superior Plastic Products Corp.
Gastroenterology & Urology · 76d
Cleared Jul 26, 1984
ELECTRODE PLACEMENT ARM PART GARMENT
K842033 · GXY
Bio-Stimu Trend Corp.
Neurology · 66d
Cleared Jul 26, 1984
HEMODIALYSIS BATH CONCENTRATE SOLUTION
K842058 · FKQ
Pharmaceutical Development Systems
Gastroenterology & Urology · 65d