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
129193–129216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 1989
COULTER POSITIVE CONTROL CELLS
K894651 · GGL
Coulter Corp.
Hematology · 51d
Cleared Sep 13, 1989
ELECTROTRACE DISP. RESTING EKG ELECTRODES
K894679 · DRX
Jason Marketing Co.
Cardiovascular · 50d
Cleared Sep 13, 1989
MODEL 6888 LEAD TUNNELER
K894738 · DWS
Cardiac Pacemakers, Inc.
Cardiovascular · 48d
Cleared Sep 13, 1989
TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT
K894761 · CGJ
Hybritech, Inc.
Chemistry · 48d
Cleared Sep 13, 1989
MEL-PAK GENERAL DRUG DELIVERY SYSTEM KIT
K894787 · FPA
New York Blood Center, Inc.
General Hospital · 44d
Cleared Sep 13, 1989
IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST
K894975 · KTN
General Biometrics, Inc.
Immunology · 37d
Cleared Sep 13, 1989
ACE BEADED K-WIRES ACE OLIVE WIRES
K895079 · HTY
Buckman Co., Inc.
Orthopedic · 30d
Cleared Sep 12, 1989
THE SAFEGARD PERSONAL PROTECTION KIT
K884692 · HIS
The Safegard Protection Corp.
Obstetrics & Gynecology · 307d
Cleared Sep 12, 1989
MODIFIED URINARY CATHETER INTRODUCER (UCI)
K890400 · KOD
Go Medical Industries Pty. , Ltd.
Gastroenterology & Urology · 231d
Cleared Sep 12, 1989
GUIDEWIRE
K890959 · DQX
Guidewire Technologies, Inc.
Cardiovascular · 197d
Cleared Sep 12, 1989
OPTIMA MPT AND SPT PACEMAKERS
K891231 · DXY
Telectronics, Inc.
Cardiovascular · 189d
Cleared Sep 12, 1989
COMPAT ENTERAL FEED PUMP 199235 & 199240
K891575 · LZH
Sandoz Nutrition
General Hospital · 176d
Cleared Sep 12, 1989
MODIFIED OSTEOANALYZER (# SPSHA110/220)
K891582 · KGI
Osteon, Inc.
Radiology · 176d
Cleared Sep 12, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K892035 · LYY
Fine Spring Ent. Co., Ltd.
General Hospital · 165d
Cleared Sep 12, 1989
DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A
K892386 · IYO
Toshiba America Medical Systems, In.C
Radiology · 158d
Cleared Sep 12, 1989
WRIGHT MEDICAL FETASAFE
K892501 · HGM
Wright Medical Corp.
Obstetrics & Gynecology · 160d
Cleared Sep 12, 1989
LATEX EXAMINATION GLOVES
K893235 · LYY
Quingdao Latex Factory
General Hospital · 137d
Cleared Sep 12, 1989
LATEX EXAMINATION GLOVES
K893339 · LYY
Kenmark Industrial Co., Ltd.
General Hospital · 145d
Cleared Sep 12, 1989
DISPOSABLE VINYL (PVC) EXAMINATION GLOVES
K893796 · LYZ
Anmei Plastic & Rubber Products Co. ,...
General Hospital · 113d
Cleared Sep 12, 1989
RELIANCE(R) 6200 EXAMINATION CHAIR
K894018 · HME
Reliance Medical Products, Inc.
Ophthalmic · 98d
Cleared Sep 12, 1989
5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER
K894054 · IYN
Advanced Technology Laboratories, Inc.
Radiology · 97d
Cleared Sep 12, 1989
PHASE 2 TRANSCRANIAL PROBE
K894163 · IYN
Biosound, Inc.
Radiology · 90d
Cleared Sep 12, 1989
NEEDLE*LESS DRUG VIAL ADAPTER
K894177 · FMF
Baxter Healthcare Corp
General Hospital · 89d
Cleared Sep 12, 1989
SURGIFLEX LASER CONTACT TIPS
K894186 · GEX
Cabot Medical Corp.
General & Plastic Surgery · 88d