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
122425–122448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 1991
CORDIS REFLEX STEERABLE GUIDEWIRE
K905423 · DQX
Cordis Corp.
Cardiovascular · 87d
Cleared Mar 01, 1991
PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM
K905530 · BYT
Puritan Bennett Corp.
Anesthesiology · 81d
Cleared Mar 01, 1991
MICRORATE INTELLIGENT PUMP
K905610 · FRN
Kendall Mcgaw Laboratories, Inc.
General Hospital · 80d
Cleared Mar 01, 1991
MICRORATE PLUS INTELLIGENT PUMP
K905611 · FRN
Kendall Mcgaw Laboratories, Inc.
General Hospital · 80d
Cleared Feb 28, 1991
BLOM-SINGER SHOWER GUARD
K904729 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 134d
Cleared Feb 28, 1991
NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS
K905248 · DQK
Advanced Technology Laboratories, Inc.
Cardiovascular · 99d
Cleared Feb 28, 1991
THE EYEGAZE SYSTEM
K905474 · ILQ
Lc Technologies, Inc.
Physical Medicine · 84d
Cleared Feb 28, 1991
ALOKA UST-952DP-5 ENDOVAGINAL TRANSDUCER
K905535 · ITX
Ge Medical Systems Information...
Radiology · 80d
Cleared Feb 28, 1991
LAP 3501 HIGH FLOW INSUFFLATOR
K905705 · HIF
Circon Acmi
Obstetrics & Gynecology · 66d
Cleared Feb 28, 1991
GYN-1500 HYSTEROSCOPIC INUFFLATOR
K905706 · HIG
Circon Acmi
Obstetrics & Gynecology · 66d
Cleared Feb 28, 1991
PHONAK MODEL PICO C-S-H-T, BTE HEARING AID
K910012 · ESD
Phonak, Inc.
Ear, Nose, Throat · 57d
Cleared Feb 28, 1991
POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC
K910018 · ESD
Phonak, Inc.
Ear, Nose, Throat · 55d
Cleared Feb 28, 1991
OTT CERVICAL TENACULUM
K910287 · HDC
Marlo Surgical Technology
Obstetrics & Gynecology · 37d
Cleared Feb 28, 1991
OVARIAN ASPIRATION/IRRIGATION NEEDLE
K910579 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 17d
Cleared Feb 28, 1991
ACTIVE MODEL AST CUSTOM ITE HEARING AID
K910700 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Feb 28, 1991
ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID
K910701 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Feb 28, 1991
ACTIVE MODEL AHS HALF SHELL ITE HEARING AID
K910702 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Feb 28, 1991
ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID
K910703 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Feb 28, 1991
ACTIVE MODEL AMC MINI CANAL ITE HEARING AID
K910704 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Feb 28, 1991
ACTIVE MODEL AHX HELIX ITE HEARING AID
K910705 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Feb 28, 1991
PHILIPS MODEL S46-OL BTE HEARING AID
K910743 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 7d
Cleared Feb 28, 1991
PHILIPS MODEL S46-O BTE HEARING AID
K910744 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 7d
Cleared Feb 28, 1991
3M MODEL 8241 ITE HEARING AID
K910759 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8242 ITE HEARING AID
K910760 · ESD
3M Company
Ear, Nose, Throat · 9d