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
132865–132888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1988
LABILE LYSING REAGENT
K884315 · LCP
Helena Laboratories
Hematology · 75d
Cleared Dec 27, 1988
PROPAQ 106(TM)
K884320 · DRT
Protocol Systems, Inc.
Cardiovascular · 75d
Cleared Dec 27, 1988
CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI
K884346 · GKZ
Coulter Immunology
Hematology · 74d
Cleared Dec 27, 1988
MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
K884347 · GXI
Advanced Surgical Products, Inc.
Neurology · 74d
Cleared Dec 27, 1988
MODIFIED SHILEY FEMORAL ARTERIAL CANNULA
K884393 · DWF
Shiley, Inc.
Cardiovascular · 77d
Cleared Dec 27, 1988
PHARMASEAL STERILE WOUND CARE DRESSING
K884397 · FRO
Baxter Healthcare Corp
General & Plastic Surgery · 69d
Cleared Dec 27, 1988
KVM BLOOD CELL COUNTER
K884471 · GKL
Kvm Instruments, Inc.
Hematology · 63d
Cleared Dec 27, 1988
FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY
K884683 · DBF
Serono-Baker Diagnostics, Inc.
Chemistry · 49d
Cleared Dec 27, 1988
KARMA-RS, KARMA-FS WHEELCHAIRS
K884812 · ITI
Orthofab, Inc.
Physical Medicine · 40d
Cleared Dec 27, 1988
ABBOTT SPECTRUM(R) BICARBONATE REAGENT
K884821 · KHS
Abbott Laboratories
Chemistry · 40d
Cleared Dec 27, 1988
ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE
K884862 · GES
Anchor Products Co.
General & Plastic Surgery · 36d
Cleared Dec 27, 1988
BUMPY MEDICAL MASSAGE MAT
K884907 · LYG
Medical Flotation Systems, Inc.
Physical Medicine · 34d
Cleared Dec 27, 1988
ULTRAFLOTATION MEDICAL WHEELCHAIR
K884908 · INF
Medical Flotation Systems, Inc.
Physical Medicine · 34d
Cleared Dec 27, 1988
CARDIOCAP(TM) CTO-104 MONITOR
K884956 · DPS
Datex Division Instrumentarium Corp.
Cardiovascular · 28d
Cleared Dec 27, 1988
MODIFIED Q-SERIES OF TREADMILLS
K885062 · IOL
Quinton, Inc.
Physical Medicine · 21d
Cleared Dec 27, 1988
1600 LIGHT TOUCH CONTROL
K885103 · ITI
Rolcontrol Products, Co., Inc.
Physical Medicine · 15d
Cleared Dec 27, 1988
LAYDOWN ARM SUPPORT MECHANISM
K885104 · KNN
Rolcontrol Products, Co., Inc.
Physical Medicine · 15d
Cleared Dec 27, 1988
SLIDING ARM SUPPORT
K885105 · KNN
Rolcontrol Products, Co., Inc.
Physical Medicine · 15d
Cleared Dec 27, 1988
REMOVABLE BATTERY POWER SYSTEM
K885106 · KNN
Rolcontrol Products, Co., Inc.
Physical Medicine · 15d
Cleared Dec 23, 1988
MEDITRODE KIT
K882554 · EGJ
Life-Tech Intl., Inc.
Physical Medicine · 185d
Cleared Dec 22, 1988
STERA DISPOSABLE SYRINGES
K881791 · FMF
Excel U.S.A.
General Hospital · 240d
Cleared Dec 22, 1988
HEMODIALYSIS CONCENTRATES
K883068 · KPO
Dove Medical Supplies
Gastroenterology & Urology · 155d
Cleared Dec 22, 1988
AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT
K883123 · CEC
Amersham Corp.
Chemistry · 149d
Cleared Dec 22, 1988
ORTHO* SYPHILIS-M ANTIBODY ELISA TEST
K883938 · LIP
Ortho Diagnostic Systems, Inc.
Microbiology · 94d