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
133657–133680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 1988
PROTECT-AIDS UNDERGLOVE
K880439 · LYU
Medical Armor Corp.
General Hospital · 252d
Cleared Oct 11, 1988
PROTECT-AIDS AUTOPSY UNDERGLOVE
K880440 · LYU
Medical Armor Corp.
General Hospital · 252d
Cleared Oct 11, 1988
P-7 COMPUTED TOMOGRAPHY SYSTEM
K882378 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 125d
Cleared Oct 11, 1988
AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA
K882736 · JJY
Amersham Corp.
Chemistry · 102d
Cleared Oct 11, 1988
SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25
K883264 · IYE
Philips Medical Systems, Inc.
Radiology · 70d
Cleared Oct 11, 1988
FOCUS TOTAL HIP SYSTEM
K883460 · JDI
Depuy, Inc.
Orthopedic · 57d
Cleared Oct 11, 1988
TDX CANNABINOIDS-GS
K883731 · LDJ
Abbott Laboratories
Toxicology · 41d
Cleared Oct 11, 1988
EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A
K883920 · DLJ
Syva Co.
Toxicology · 25d
Cleared Oct 11, 1988
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
K884022 · DKZ
Syva Co.
Toxicology · 19d
Cleared Oct 11, 1988
TECNOL BUCKS TRACTION W/HEEL PROTECTOR
K884132 · KQZ
Technol, Inc.
Orthopedic · 11d
Cleared Oct 07, 1988
SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER
K873674 · JOP
Shimadzu Corp.
Cardiovascular · 392d
Cleared Oct 07, 1988
LENZ CLENZER
K881739 · LYL
Lens Care, Inc.
Ophthalmic · 165d
Cleared Oct 07, 1988
VIADERM
K882590 · KGN
Applied Biomedical Sciences
General & Plastic Surgery · 106d
Cleared Oct 07, 1988
DVS (OPTION 01)
K883101 · IYE
O.M.I. Oncology Microsystems, Inc.
Radiology · 77d
Cleared Oct 07, 1988
AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR
K883483 · CAN
Autoflow Products, Co.
Anesthesiology · 52d
Cleared Oct 07, 1988
DIASONICS MT/P IMAGING SYSTEM
K883516 · LNH
Diasonics, Inc.
Radiology · 52d
Cleared Oct 07, 1988
0.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYST
K883520 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 50d
Cleared Oct 07, 1988
TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCER
K883546 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 49d
Cleared Oct 07, 1988
WILLIAMS-FRITTS PLEURAL BIOPSY NEEDLE
K883876 · GDM
E.G. Dick & Assoc.
General & Plastic Surgery · 24d
Cleared Oct 07, 1988
RANEY AND LEROY-RANEY SCALP CLIP
K883963 · HBO
New England Surgical Instrument Corp.
Neurology · 17d
Cleared Oct 07, 1988
NON-REBREATHING TEE PIECE (NRTP)
K883988 · CBP
Dhd Medical Products Div. Diemolding...
Anesthesiology · 17d
Cleared Oct 07, 1988
MASTER-GUARD
K884041 · KCT
Sparco, Inc.
General Hospital · 11d
Cleared Oct 07, 1988
ROCKET CERVICAL SPATULA
K884042 · HHT
A & A Medical, Inc.
Obstetrics & Gynecology · 11d
Cleared Oct 07, 1988
15 MILLIMETER MALE AND FEMALE ADAPTERS
K884072 · CAI
Eastmed Enterprises, Inc.
Anesthesiology · 10d