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
135889–135912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1988
ELITE MODULAR HIP SYSTEM
K871867 · JDI
Thackray USA
Orthopedic · 331d
Cleared Apr 08, 1988
MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR
K874137 · FKT
Ash Medical Systems, Inc.
Gastroenterology & Urology · 178d
Cleared Apr 08, 1988
INTELECT MODEL 120
K880235 · IPF
Chattanooga Group, Inc.
Physical Medicine · 79d
Cleared Apr 08, 1988
ARCHGAUGE(TM)
K881024 · IPF
Archxerciser Corp.
Physical Medicine · 29d
Cleared Apr 08, 1988
YESNG PATIENT PLATE #80226
K881144 · JOS
Ferguson Medical
General & Plastic Surgery · 22d
Cleared Apr 08, 1988
ENDICOTT & BEAMAN SUPRA-TEC FACE MASK
K881372 · FXX
Endicott & Beaman, Inc.
General Hospital · 7d
Cleared Apr 08, 1988
NON-STERILE SUTURE NEEDLES
K881394 · GDL
China National Medicines C/O Havel'S
General & Plastic Surgery · 4d
Cleared Apr 07, 1988
SIM 4000I
K873845 · IYO
Ote-Biomedica Elettronica S.P.A
Radiology · 198d
Cleared Apr 07, 1988
IVT CENTRAL ALLERGY SCREEN
K875329 · DHB
In Vitro Technologies, Inc.
Immunology · 99d
Cleared Apr 07, 1988
AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)
K875346 · GKZ
Contraves Medical Instruments, Inc.
Hematology · 98d
Cleared Apr 07, 1988
N PROTEIN STANDARD PLASMA (HUMAN)
K880356 · CFN
Behring Diagnostics, Inc.
Immunology · 72d
Cleared Apr 07, 1988
ORTHOLUX VISIBLE LIGHT CURING UNIT
K880392 · EBZ
Unitek Corp.
Dental · 69d
Cleared Apr 07, 1988
VITALLIUM EQUIPOISE ALLOY
K880875 · EJH
Austenal Dental, Inc.
Dental · 37d
Cleared Apr 07, 1988
GENERAL PURPOSE KIT
K881083 · LRO
Med-Dex Intl.
General & Plastic Surgery · 24d
Cleared Apr 07, 1988
THERMAFIL ENDODONTIC OBTURATOR
K881139 · EKM
Tulsa Dental Products, Ltd.
Dental · 21d
Cleared Apr 07, 1988
RECTANGULAR NITINOL ARCH WIRE
K881163 · EJF
Flexmedics
Dental · 20d
Cleared Apr 07, 1988
MONO-PHILE
K881247 · KTN
Bio Diagnostic Systems, Inc.
Immunology · 15d
Cleared Apr 07, 1988
ALLEN LATERAL ARMBOARD
K881292 · BTX
Edgewater Medical Systems, Inc.
General & Plastic Surgery · 10d
Cleared Apr 06, 1988
CONDOMS (HOMBRE BLACK/BLACK SATIN/XT-12/ORION)
K872356 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 293d
Cleared Apr 06, 1988
SAFECON CONDOMS
K874399 · HIS
Quality Synthetics Intl, Inc.
Obstetrics & Gynecology · 161d
Cleared Apr 06, 1988
QUIDEL ALLERGY SCREEN
K874717 · DHB
Quidel Corp.
Immunology · 141d
Cleared Apr 06, 1988
EFFNER FE-EX* OROGASTRIC
K874755 · KNT
Effner and Spreine Co.
Gastroenterology & Urology · 140d
Cleared Apr 06, 1988
J-CATH(TM)
K875171 · KNT
Hdc Corp.
Gastroenterology & Urology · 111d
Cleared Apr 06, 1988
MEDELA BREAST-PUMP LACTINA
K875300 · HGX
Medela, Inc.
Obstetrics & Gynecology · 99d