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
121201–121224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 1991
AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT
K910942 · FSS
Mdt Biologic Co.
General & Plastic Surgery · 97d
Cleared Jun 11, 1991
PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1
K911104 · FEX
Hgm Medical Laser Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 11, 1991
HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
K911139 · DRT
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Jun 11, 1991
ELECTROCAUTERY CABLE, BOVIE(TM)/BANANA PLUGS
K911365 · GEI
Northgate Technologies, Inc.
General & Plastic Surgery · 75d
Cleared Jun 11, 1991
GESCO UMBILI-CATH
K911607 · FOS
Gesco Intl., Inc.
General Hospital · 62d
Cleared Jun 11, 1991
OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE
K911639 · LIT
Vas-Cath, Inc.
Cardiovascular · 111d
Cleared Jun 11, 1991
CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP
K911791 · MEA
Pharmacia Deltec, Inc.
General Hospital · 50d
Cleared Jun 11, 1991
ENDOSCOPIC CLIP APPLIER
K911817 · GCJ
Surgitech C/O Collier, Shannon, Rill...
General & Plastic Surgery · 48d
Cleared Jun 11, 1991
DADE(R) PROTEIN C ABNORMAL CONTRAL
K911885 · GGC
Baxter Healthcare Corp
Hematology · 43d
Cleared Jun 11, 1991
LASERSCOPE DISPOSABLE LAPAROSTAT W/IRRIG & ASPIR
K912023 · GCJ
Laserscope
General & Plastic Surgery · 35d
Cleared Jun 11, 1991
VZVSCAN(TM) LATEX AGGUTINATION TEST
K912239 · GQW
Bd Becton Dickinson Vacutainer...
Microbiology · 21d
Cleared Jun 10, 1991
BABYLOG 8000 INFANT VENTILATOR
K903089 · CBK
Drager, Inc.
Anesthesiology · 332d
Cleared Jun 10, 1991
SYSTEM 70 AND 100
K904246 · ITI
Folio Products, Inc.
Physical Medicine · 269d
Cleared Jun 10, 1991
SYSTEM 50
K905292 · ITI
Folio Products, Inc.
Physical Medicine · 199d
Cleared Jun 10, 1991
ABUTMENT GLO
K905303 · EJR
Implant Innovations International, Inc.
Dental · 194d
Cleared Jun 10, 1991
EIA FOR DETECTION OF ANTIBODIES H. PYLORI
K905409 · LYR
E-Z-Em, Inc.
Microbiology · 189d
Cleared Jun 10, 1991
MYOCARDIAL PROTECTION SYSTEM
K905500 · DTR
Medtronic Vascular
Cardiovascular · 185d
Cleared Jun 10, 1991
QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER
K905753 · KGI
Hologic, Inc.
Radiology · 168d
Cleared Jun 10, 1991
COLLAGEN SHIELD, VARIOUS MODELS
K905825 · MOE
Chiron Ophthalmics
Ophthalmic · 161d
Cleared Jun 10, 1991
BROWNE MEDICAL SYSTEMS IMAGEPRO
K910444 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 131d
Cleared Jun 10, 1991
CARD GUARD, MODEL CG-2000A
K910451 · DXH
Medtech Industries, Inc.
Cardiovascular · 129d
Cleared Jun 10, 1991
RADIOACTIVE SEEDS
K910710 · KXK
Best Assoc. Corp.
Radiology · 110d
Cleared Jun 10, 1991
BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
K910720 · FCG
C.R. Bard, Inc.
Gastroenterology & Urology · 110d
Cleared Jun 10, 1991
LYME DISEASE MICROASSAY
K910899 · LSR
Diamedix Corp.
Microbiology · 105d