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
108433–108456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 1994
MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE
K934011 · HDB
Neward Enterprises, Inc.
Obstetrics & Gynecology · 260d
Cleared May 04, 1994
MINI FRAGMENT PLATE
K934614 · HRS
Onyx Medical Corp.
Orthopedic · 219d
Cleared May 04, 1994
MEDTRONIC GCIII CORONARY GUIDING CATHETER
K935738 · DQY
Medtronics Interventional Vascular
Cardiovascular · 154d
Cleared May 04, 1994
MIRACLE-EAR WITH POWER CIRCUIT OPTION
K935962 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 142d
Cleared May 04, 1994
SYSTEM, X-RAY, MAMOGRAPHIC
K936161 · IZH
Technowipe
Radiology · 128d
Cleared May 04, 1994
ANTITHROMBIN III CHROMOGENIC ASSAY
K936196 · JBQ
Baxter Diagnostics, Inc.
Hematology · 126d
Cleared May 04, 1994
AMG MED BRAND CLINICAL GLASS THERMOMETER
K940380 · FLK
Amg Medical, Inc.
General Hospital · 98d
Cleared May 04, 1994
AMG MED BRAND CLINICAL GLASS THERMOMETER
K940394 · FLK
Technolab Industries (Canada) , Ltd.
General Hospital · 98d
Cleared May 04, 1994
ALGINATE FIBER TOPICAL WOUND DRESSING
K940404 · KMF
Adri
General & Plastic Surgery · 97d
Cleared May 04, 1994
OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)
K940508 · OKS
G.W.B. Intl., Ltd.
Ophthalmic · 89d
Cleared May 04, 1994
MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER
K940521 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 89d
Cleared May 04, 1994
COE-SOFT LC
K940565 · EBI
GC America, Inc.
Dental · 85d
Cleared May 04, 1994
155 PP AGC-I
K940608 · ESD
Danavox, Inc.
Ear, Nose, Throat · 79d
Cleared May 04, 1994
3M TEGASORB HYDROCOLLOID DRESSING
K940624 · KMF
3M Company
General & Plastic Surgery · 79d
Cleared May 04, 1994
STARKEY EUROLINE A SERIES
K940978 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 64d
Cleared May 04, 1994
BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING
K941019 · NAE
Brady Medical Products Co.
General & Plastic Surgery · 62d
Cleared May 04, 1994
RIONET HEARING AID HB-54
K941021 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 62d
Cleared May 04, 1994
RIONET HEARING AID HB-37T
K941140 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 55d
Cleared May 04, 1994
FLEXIBLE GRASPING FORCEPS
K941161 · EOQ
Surgical Technologies, Inc.
Ear, Nose, Throat · 54d
Cleared May 04, 1994
BELTON MERIT (HEARING AID)
K941395 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 43d
Cleared May 04, 1994
WIDEX S-21
K941508 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 36d
Cleared May 04, 1994
INTRA S, INTRA SH
K941635 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared May 04, 1994
MINI PAK
K941636 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared May 03, 1994
TCPO2 9260 MODULE - SYSTEM ATHENA
K913013 · LKD
S & W Medico Teknik
Anesthesiology · 1030d