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
149425–149448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1985
DIRECT BILIRUBIN FOR DEMAND ANALYZER
K850379 · CIG
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Mar 01, 1985
INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER
K850380 · CEO
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Mar 01, 1985
MAGNESIUM REAGENT FOR DEMAND ANALYZER
K850381 · JGJ
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Mar 01, 1985
PRL QUIK RIA KIT
K850383 · CFT
Pacific Biotech, Inc.
Chemistry · 28d
Cleared Mar 01, 1985
CARDIO-3 CHANNEL ELECTROCARDIOGRAPH
K850454 · DPS
Zimmer Elektromedizin GmbH
Cardiovascular · 23d
Cleared Mar 01, 1985
MICRO-AIRE STERNUM SAW REPLACEMENT BLADES
K850483 · DWH
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 22d
Cleared Mar 01, 1985
MICRO-AIRE GENERIC BURS & DRILLS
K850497 · GFF
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 21d
Cleared Mar 01, 1985
LISTER BANDAGE SCISSORS 6-0063(3,5 - 500 PCS
K850500
The Huxley Instrument Corp.
General & Plastic Surgery · 21d
Cleared Mar 01, 1985
LISTER BANDAGE SCISSORS (6-0064)-4.5 500PCS.
K850501
The Huxley Instrument Corp.
General & Plastic Surgery · 21d
Cleared Mar 01, 1985
H/G CUP POSITIONER (1520) LEFT-500PCS RIGHT 500PCS
K850502
The Huxley Instrument Corp.
General & Plastic Surgery · 21d
Cleared Mar 01, 1985
SURGICUTT - BLEEDING TIME DEVICE
K850542 · JCA
International Technidyne Corp.
Hematology · 18d
Cleared Mar 01, 1985
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A
K850582 · CZP
Applications Lab
Immunology · 16d
Cleared Mar 01, 1985
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G
K850583 · DEW
Applications Lab
Immunology · 16d
Cleared Mar 01, 1985
SPQ TEST SYSTEM FOR COMPLEMENT C4
K850585 · DBI
Applications Lab
Immunology · 16d
Cleared Mar 01, 1985
SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN
K850590 · DCK
Applications Lab
Immunology · 16d
Cleared Mar 01, 1985
COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM
K850656 · DXY
Cook Pacemaker Corp.
Cardiovascular · 10d
Cleared Mar 01, 1985
SUNTECH MODELS 3001 ALLSTAR & 3401 GALAXY
K850660 · FTC
Suntech USA, Inc.
General & Plastic Surgery · 9d
Cleared Feb 28, 1985
NETHERY EXTREMITY FREEZING UNIT
K844246 · GEH
Howard J. Nethery & Assoc.
General & Plastic Surgery · 119d
Cleared Feb 28, 1985
HEARING AIDS MODELS IMS, ISD, ICL & IHX
K844478
The Ite Co.
Gastroenterology & Urology · 101d
Cleared Feb 28, 1985
COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720
K844993 · FCG
Omnis Surgical, Inc.
Gastroenterology & Urology · 64d
Cleared Feb 28, 1985
MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN
K850129 · GEI
Consolidated Medical Equipment, Inc.
General & Plastic Surgery · 45d
Cleared Feb 28, 1985
VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.
K850133 · KGX
Consolidated Medical Equipment, Inc.
General & Plastic Surgery · 45d
Cleared Feb 28, 1985
MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL-
K850176 · FAD
Mentor Corp.
Gastroenterology & Urology · 42d
Cleared Feb 28, 1985
MBM(TM) MONITRAL (R) BICARBONATE MODULE
K850179 · FKP
Hospal Medical Corp.
Gastroenterology & Urology · 42d