FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
151849–151872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 26, 1984
CEFONICID 30 MCG SENSITIVITY DISCS
K842292 · JTN
Difco Laboratories, Inc.
Microbiology · 45d
Cleared Jul 26, 1984
DELTON * OPAQUE LIGHT CURING PIT
K842392 · EBC
Johnson & Johnson Professionals, Inc.
Dental · 38d
Cleared Jul 26, 1984
DUO FLOW CATHETER-MC 54
K842416 · KNZ
Medical Components, Inc.
Gastroenterology & Urology · 36d
Cleared Jul 26, 1984
RAPID PLASMA REAGIN CARD TEST
K842541 · GMQ
Clinical Sciences, Inc.
Microbiology · 24d
Cleared Jul 26, 1984
STAR HCG MONOCLONAL ANTIBODY IMMUNO
K842598 · JHI
Syncor Intl. Corp.
Chemistry · 35d
Cleared Jul 26, 1984
SUPER PETAL SOFT PLASTIC APPLICATOR TAMP
K842618 · HEB
Tambrands, Inc.
Obstetrics & Gynecology · 21d