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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
118633–118656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1991
CARDIOVASCULAR REPAIR PATCH
K905073 · DXZ
Impra, Inc.
Cardiovascular · 406d
Cleared Dec 20, 1991
INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYST
K911116 · ITX
Interson Corp.
Radiology · 288d
Cleared Dec 20, 1991
IMMUNOWELL BORRELIA (LYME)TEST
K911590 · LSR
General Biometrics, Inc.
Microbiology · 255d
Cleared Dec 20, 1991
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT
K911880 · CAI
Bill Olson Corp.
Anesthesiology · 235d
Cleared Dec 20, 1991
MOLAR DISTALIZING ASSEMBLY
K912417 · DYJ
American Orthodontics
Dental · 203d
Cleared Dec 20, 1991
SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE
K912418 · KAM
Micromedics, Inc.
General & Plastic Surgery · 203d
Cleared Dec 20, 1991
BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS
K912712 · JDI
Biomet, Inc.
Orthopedic · 184d
Cleared Dec 20, 1991
TURBO
K912854 · IOQ
Kinetic Concepts, Inc.
Physical Medicine · 175d
Cleared Dec 20, 1991
OPTIMA
K913222 · IZO
Olympic Controls Corp.
Radiology · 154d
Cleared Dec 20, 1991
S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD
K913231 · JDI
Joint Medical Products Corp.
Orthopedic · 151d
Cleared Dec 20, 1991
CONTEMPRO2 HOME HEALTH CARE REGULATOR
K913327 · CAW
Continental Products, Inc.
Anesthesiology · 148d
Cleared Dec 20, 1991
MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST
K913358 · DXG
Ppg Industries, Inc.
Cardiovascular · 144d
Cleared Dec 20, 1991
CUSTOM TUBING PACKS
K913363 · DTL
Kroy Medical, Inc.
Cardiovascular · 144d
Cleared Dec 20, 1991
CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT
K913668 · DDB
The Binding Site, Ltd.
Immunology · 123d
Cleared Dec 20, 1991
PREALBUMIN IMMUNOLOGICAL NL TEST KIT
K913672 · JZJ
The Binding Site, Ltd.
Immunology · 123d
Cleared Dec 20, 1991
PHILIPS MAMMODIAGNOST BC
K913845 · IZH
Philips Medical Systems, Inc.
Radiology · 114d
Cleared Dec 20, 1991
TRANSQ 2
K914264 · EGJ
Iomed, Inc.
Physical Medicine · 88d
Cleared Dec 20, 1991
SOS BLOODLESS NEEDLE
K914330 · DYB
E-Z-Em, Inc.
Cardiovascular · 84d
Cleared Dec 20, 1991
ALPHA-2 MACROGLOBULIN TEST RID KIT
K914389 · DEB
The Binding Site, Ltd.
Immunology · 80d
Cleared Dec 20, 1991
PT II DISTAL CEMENT SPACER
K914406 · JDI
Osteonics Corp.
Orthopedic · 79d
Cleared Dec 20, 1991
CATHETER, URETERAL DILATOR
K914617 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 64d
Cleared Dec 20, 1991
IONTOPHORESIS DEVICE, MODIFICATION
K914621 · EGJ
Iomed, Inc.
Physical Medicine · 100d
Cleared Dec 20, 1991
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
K914952 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 45d
Cleared Dec 20, 1991
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
K914985 · DRC
E-Z-Em, Inc.
Cardiovascular · 58d