FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
129553–129576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1989
HEARING AID (IN-THE-CANAL)
K894414 · ESD
Hearing Aid Express
Ear, Nose, Throat · 72d
Cleared Sep 27, 1989
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262+
K894487 · LDR
Y
General Hospital · 71d
Cleared Sep 27, 1989
SHARPLAN CO2 LASERS FOR ARTHROSCOPIC SURGERY
K895042 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 49d
Cleared Sep 27, 1989
SECONDARY IV SET WITH PROTECTED NEEDLE
K895109 · FPA
Kendall Mcgaw Laboratories, Inc.
General Hospital · 43d
Cleared Sep 27, 1989
TIK EXTRAKTOR
K895212 · HTD
Instruments of Sweden, Inc.
General & Plastic Surgery · 40d
Cleared Sep 27, 1989
LATEX PATIENT EXAMINATION GLOVES
K895258 · LYY
Perfect Treasure Development , Ltd.
General Hospital · 37d
Cleared Sep 27, 1989
ORTHO APO B ELISA TEST SYSTEM
K895277 · MSJ
Medical Marketing Consultants, Inc.
Immunology · 35d
Cleared Sep 27, 1989
VOSS GRAFT MARKER
K895369 · KPK
Voss Medical Products
Cardiovascular · 29d
Cleared Sep 27, 1989
WAKO(TM) AUTOKIT CRP
K895598 · DCK
Wako Chemicals USA, Inc.
Chemistry · 9d
Cleared Sep 27, 1989
SURGICAL SUCTION APPARATUS
K895670 · GEA
Baker-Sundt Research, Inc.
General & Plastic Surgery · 8d
Cleared Sep 26, 1989
EXTENDED PACKAGE DATING ON VELEX WOVEN GRAFTS
K890597 · DSY
D-R Medical Systems, Inc.
Cardiovascular · 243d
Cleared Sep 26, 1989
VINYL EXAMINATION GLOVES
K891513 · LYZ
Mann Chi Trading Co., Ltd.
General Hospital · 194d
Cleared Sep 26, 1989
ESCORT PULSE OXIMETRY OPTION
K892120 · DQA
Medical Data Electronics
Anesthesiology · 179d
Cleared Sep 26, 1989
PATIENT EXAMINATION GLOVES
K892505 · LYZ
Wango Intl., Inc.
General Hospital · 167d
Cleared Sep 26, 1989
CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
K892530 · DYG
Arrow Intl., Inc.
Cardiovascular · 168d
Cleared Sep 26, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892760 · LYY
Saha Import & Export Co.
General Hospital · 168d
Cleared Sep 26, 1989
ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVER
K892851 · FRO
Johnson & Johnson Patient Care, Inc.
General & Plastic Surgery · 161d
Cleared Sep 26, 1989
'JOBSTAR' PATIENT EXAMINATION GLOVES
K892972 · LYY
Kai Sik Towa Rubber Products Sdn
General Hospital · 167d
Cleared Sep 26, 1989
SWED MED STERILE VINYL EXAMINATION GLOVES
K893017 · LYZ
New England Glove Company
General Hospital · 167d
Cleared Sep 26, 1989
SAFETY TOUCH VINYL EXAMINATION GLOVES
K893105 · LYY
Fedin Brothers Co., Inc.
General Hospital · 165d
Cleared Sep 26, 1989
LATEX EXAMINATION GLOVES
K893336 · LYY
Lai Sun Industrial Co.
General Hospital · 159d
Cleared Sep 26, 1989
SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
K893435 · DYG
Cathlab Corp.
Cardiovascular · 147d
Cleared Sep 26, 1989
MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING
K893471 · DXH
Medtronic Vascular
Cardiovascular · 145d
Cleared Sep 26, 1989
FLEXMEDICS GUIDEWIRE
K893626 · DQX
Flexmedics
Cardiovascular · 138d