FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
122545–122568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1991
3M LASER IMAGER XL
K910092 · LMC
3M Medical Products Group
Radiology · 89d
Cleared Apr 08, 1991
PLP LAPAROSCOPIC CHOLECYSTECTOMY SET
K910137 · GEX
Precision Laser Products, Inc.
General & Plastic Surgery · 89d
Cleared Apr 08, 1991
LAPAROMED CHOLANGIOGRAM VACUUM DEVICE
K910218 · GCX
Laparomed Corp.
General Hospital · 81d
Cleared Apr 08, 1991
LAPAROMED CHOLANGIOGRAM DEVICE
K910219 · FGE
Laparomed Corp.
Gastroenterology & Urology · 81d
Cleared Apr 08, 1991
10 ADJUSTABLE BELT COIL
K910269 · LNH
Resonex, Inc.
Radiology · 76d
Cleared Apr 08, 1991
TRACHEOSTOMY CARE KIT
K910362 · JOH
Megadyne Medical Products, Inc.
Anesthesiology · 69d
Cleared Apr 08, 1991
EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS
K910428 · FRN
Baxter Healthcare Corp
General Hospital · 67d
Cleared Apr 08, 1991
OSTEONICS(R) MID-SHAFT CEMENT SPACER
K910461 · JDK
Osteonics Corp.
Orthopedic · 63d
Cleared Apr 08, 1991
SYNCHRON LACTATE REAGENT
K910534 · KHP
Beckman Instruments, Inc.
Chemistry · 59d
Cleared Apr 08, 1991
ENZYMUN-TEST PROGESTERONE
K910683 · JLS
Boehringer Mannheim Corp.
Chemistry · 48d
Cleared Apr 08, 1991
EQUIPMENT/MATERIAL DECONTAMINATING KIT
K911299 · KIE
Rohm and Haas Co.
Toxicology · 14d
Cleared Apr 05, 1991
PROBET (TM)
K903002 · HFF
Gynopharma, Inc.
Obstetrics & Gynecology · 270d
Cleared Apr 05, 1991
NA ALPHA 1 MICROGLOBULIN KIT
K904254 · JZG
Behring Diagnostics, Inc.
Immunology · 203d
Cleared Apr 05, 1991
SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM
K905459 · LRO
Angiosystems, Inc.
General & Plastic Surgery · 121d
Cleared Apr 05, 1991
STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION
K905847 · LJT
Strato Medical Corp.
General Hospital · 99d
Cleared Apr 05, 1991
STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED
K905851 · LJT
Strato Medical Corp.
General Hospital · 99d
Cleared Apr 05, 1991
MAST CLA ALLERGY SYSTEM
K910292 · DHB
Mast Immunosystems
Immunology · 72d
Cleared Apr 05, 1991
PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K
K910315 · LJS
Sorex Medical
General Hospital · 71d
Cleared Apr 05, 1991
MICROLINE SCREEN FOR METHAMPHETAMINE
K910525 · DIT
Drug Screening Systems, Inc.
Toxicology · 57d
Cleared Apr 05, 1991
RHEUMAJET RF
K910539 · DHR
Biokit USA, Inc.
Immunology · 67d
Cleared Apr 05, 1991
ABUSCREEN ONTRAK FOR BENZODIAZEPINE
K910590 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 52d
Cleared Apr 05, 1991
OSTEONICS CDH HIP STEM
K910922 · JDI
Osteonics Corp.
Orthopedic · 31d
Cleared Apr 05, 1991
DERMATEK 4000
K911057 · INX
Anacom General Corp.
Physical Medicine · 28d
Cleared Apr 05, 1991
SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)
K911175 · DBF
Serono-Baker Diagnostics, Inc.
Immunology · 18d