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
128953–128976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1989
BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM
K895207 · FRO
Johnson & Johnson International
General & Plastic Surgery · 42d
Cleared Sep 28, 1989
OPSITE I.V. 3000
K895353 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 27d
Cleared Sep 28, 1989
BIO-COORDINATOR SYSTEM
K895398 · IKK
Bio-Harmonizer, Inc.
Physical Medicine · 21d
Cleared Sep 28, 1989
PRIMIDONE (FPIA) CALIBRATOR KIT
K895568 · DLJ
Tudor Laboratories, Inc.
Toxicology · 22d
Cleared Sep 28, 1989
VALPROIC ACID (FPIA) CALIBRATOR KIT
K895570 · DLJ
Tudor Laboratories, Inc.
Toxicology · 22d
Cleared Sep 27, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892635 · LYY
P.T. Multi Latexindo
General Hospital · 170d
Cleared Sep 27, 1989
PREEMICARE MODEL 2500 TRANSPORT WARMER
K893624 · FPL
Preemicare Corp.
General Hospital · 139d
Cleared Sep 27, 1989
COUNTERBORE FOR SS SUBMERGED SCREW PLANT
K894150 · DZJ
Artech Corp.
Dental · 105d
Cleared Sep 27, 1989
IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT
K894151 · DZJ
Artech Corp.
Dental · 105d
Cleared Sep 27, 1989
MODIFIED GEMINI ACETABULAR CUP
K894298 · JDI
Depuy, Inc.
Orthopedic · 97d
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