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
170569–170592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1978
SHORTWAVE THERAPY APPAR. CURAMED 401
K781320 · IMJ
General Theraphysical, Inc.
Physical Medicine · 58d
Cleared Sep 27, 1978
MARKII VENTIMASKS
K781325 · BYF
Vickers America Medical Corp.
Anesthesiology · 57d
Cleared Sep 27, 1978
RESURFACE PROSHESIS
K781343
Aesculap Instruments Corp.
Orthopedic · 54d
Cleared Sep 27, 1978
INTERFACE CARDIOTOMY BLOOD FILTER
K781383 · JOD
Medical, Inc.
Cardiovascular · 47d
Cleared Sep 27, 1978
ERM-101
K781407 · DRT
Cynergy
Cardiovascular · 44d
Cleared Sep 27, 1978
IMMO PHASE, THYROID HORMONE
K781409 · JLW
Corning Medical & Scientific
Chemistry · 44d
Cleared Sep 27, 1978
RIALYZE VITAMIN B-12 TEST
K781410 · CDD
Ames Div., Miles Laboratories, Inc.
Chemistry · 44d
Cleared Sep 27, 1978
GENERATORS: UDL-201B, BDL-201B, MDL-201B
K781424 · DXY
Pacesetter Systems
Cardiovascular · 41d
Cleared Sep 27, 1978
MS-2 BACTERIAL ID. SYSTEM
K781427 · JSS
Abbott Laboratories
Microbiology · 36d
Cleared Sep 27, 1978
HARRINGTON SPINE INSTRUMENTATION
K781443 · KWP
Orthopedic Equipment Co., Inc.
Orthopedic · 35d
Cleared Sep 27, 1978
OUTRIGGER DISTRACTION UNIT
K781444 · KWP
Orthopedic Equipment Co., Inc.
Orthopedic · 35d
Cleared Sep 27, 1978
C RING CLINCHER
K781446 · GEN
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 35d
Cleared Sep 27, 1978
THREADED ROD CLAMP
K781447 · GEN
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 35d
Cleared Sep 27, 1978
HARRINGTON HOOK CLAMP
K781448 · GEN
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 35d
Cleared Sep 27, 1978
HARRINGTON SPINAL ELEVATOR
K781449 · GEG
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 35d
Cleared Sep 27, 1978
DRIVERS
K781450 · GFC
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 35d
Cleared Sep 27, 1978
FLAT WRENCH
K781451 · HXS
Orthopedic Equipment Co., Inc.
Orthopedic · 35d
Cleared Sep 27, 1978
MITROPHENYL, ALKALINE PHOSPHATES
K781472 · CJE
Beckman Instruments, Inc.
Chemistry · 30d
Cleared Sep 27, 1978
ORTHO*T-3 RIA (PEG) KIT
K781481 · CDP
Ortho Diagnostics, Inc.
Chemistry · 30d
Cleared Sep 27, 1978
ORTHO*T-3 UPTAKE KIT
K781482 · KHQ
Ortho Diagnostics, Inc.
Chemistry · 30d
Cleared Sep 27, 1978
ORTHO*T-4 RIA (PEG) KIT
K781483 · CDX
Ortho Diagnostics, Inc.
Chemistry · 30d
Cleared Sep 27, 1978
STERI-VAC POWER UNITS
K781486 · EHZ
Cpac, Inc.
Dental · 30d
Cleared Sep 27, 1978
MVS-MODEL SEU-6, DEU-6
K781488 · EHZ
Dentsply Intl.
Dental · 30d
Cleared Sep 27, 1978
PRO-MOLD, CUSTOM EAR
K781491 · EWD
Mcghan Medical Corp.
Ear, Nose, Throat · 30d