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
102985–103008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 1995
ANDAL
K950823 · LYY
Pt. Sarana Indoprotex
General Hospital · 76d
Cleared May 10, 1995
INTRAORAL VIDEO SCOPE AND WINDOW TUBE
K951019 · EIA
Cuda Products Co.
Dental · 64d
Cleared May 10, 1995
ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION
K951063 · JOJ
Pymah Corp.
General Hospital · 63d
Cleared May 10, 1995
SUNGLASSES, NONPRESCRIPTION
K951131 · HQY
Gold, Inc.
Ophthalmic · 58d
Cleared May 10, 1995
MARINR SERIES EP DIAGNOSTI CATHETERS
K951347 · DRF
Medtronic Cardiorhythm
Cardiovascular · 71d
Cleared May 10, 1995
CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS, STRIPS
K951417 · MGQ
Carrington Laboratories, Inc.
General & Plastic Surgery · 43d
Cleared May 10, 1995
BENSON AND ASHLEY
K951438 · HQY
Benson & Ashley, Inc.
Ophthalmic · 44d
Cleared May 10, 1995
CVD BULLET INFUSION CATYHETER
K951502 · KRA
Cardiovascular Dynamics, Inc.
Cardiovascular · 43d
Cleared May 10, 1995
ULTRADENT PORCELAIN ETCH
K951582 · EIH
Ultradent Products, Inc.
Dental · 34d
Cleared May 10, 1995
DSL ACTIVE IFGBP-3 ELISA
K951707 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 27d
Cleared May 10, 1995
ACTIVE IGF-I ELISA
K951752 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 23d
Cleared May 10, 1995
JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS
K951917 · JES
Johnson & Johnson Consumer Products,...
Dental · 16d
Cleared May 10, 1995
EMI MODEL FFF-IA
K952164 · DQK
New York Heart Instruments, Inc.
Cardiovascular · 7d
Cleared May 09, 1995
ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON
K945230 · DSP
Arrow Intl., Inc.
Cardiovascular · 195d
Cleared May 09, 1995
BENCHMARK SERIES ARTHROSCCOPIC INSTRUMENTS
K946151 · HRX
Depuy, Inc.
Orthopedic · 144d
Cleared May 09, 1995
GENTAL PULSE
K950238 · EAT
Parkell, Inc.
Dental · 109d
Cleared May 09, 1995
CORDIS CSF RESERVOIR
K950315 · LKG
Cordis Corp.
General Hospital · 103d
Cleared May 09, 1995
SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000
K950495 · BTA
Surgical Dynamics, Inc.
General & Plastic Surgery · 92d
Cleared May 09, 1995
IMPLANTABLE STAPLE
K950562 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 90d
Cleared May 09, 1995
BIO-APATITE 6140 HA PARTICLES
K950567 · LYC
Bio-Interfaces, Inc.
Dental · 90d
Cleared May 09, 1995
LSU 2000 PORTABLE SUCTION UNIT
K950698 · JCX
Laerdal Medical Corp.
General & Plastic Surgery · 88d
Cleared May 09, 1995
1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE
K950705 · HRX
Neuro Navigational Corp.
Orthopedic · 83d
Cleared May 09, 1995
TROCAR SUPRAPUBIC, NON-DISPOSABLE TROCAR, DISPOSABLE
K950959 · GCJ
Miller Instrument, Inc.
General & Plastic Surgery · 68d
Cleared May 09, 1995
MC ACCLAIM Q6000 BED
K951161 · FNL
Janco Consulting Services
General Hospital · 56d