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
81001–81024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 2000
LOOK COLLAGEN SPACERS, MODEL 1514B
K001765 · KXK
Surgical Specialties Corp
Radiology · 87d
Cleared Sep 07, 2000
I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411
K001872 · FPA
Codan US Corp.
General Hospital · 79d
Cleared Sep 07, 2000
NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM,...
K002060 · HIS
Dongkuk Techco Rubber Industries
Obstetrics & Gynecology · 63d
Cleared Sep 06, 2000
BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020
K000743 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 183d
Cleared Sep 06, 2000
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT...
K001149 · DWJ
Augustine Medical, Inc.
Cardiovascular · 149d
Cleared Sep 06, 2000
GYROSCAN INTERA (R7.5)
K001796 · LNH
Philips Medical Systems North...
Radiology · 84d
Cleared Sep 06, 2000
EXPLORER GRADIENT
K001987 · LNH
Philips Medical Systems North...
Radiology · 69d
Cleared Sep 06, 2000
BREEZE SLEEPGEAR WITH DREAMSEAL
K002001 · BZD
Puritan Bennett Corp.
Anesthesiology · 68d
Cleared Sep 06, 2000
PHILIPS INTEGRIS ALLURA
K002016 · OWB
Philips Medical Systems North...
Radiology · 65d
Cleared Sep 06, 2000
CAPIOX ARTERIAL FILTER
K002026 · DTM
Terumo Medical Corp.
Cardiovascular · 65d
Cleared Sep 06, 2000
S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE
K002158 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 51d
Cleared Sep 06, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K002574 · DQA
Masimo Corp.
Anesthesiology · 19d
Cleared Sep 06, 2000
DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550
K002655 · DXN
Meditec Co., Ltd.
Cardiovascular · 12d
Cleared Sep 06, 2000
COAGUCHEK S SYSTEM, MODEL 2138280
K994349 · JPA
Roche Diagnostics Corp.
Hematology · 258d
Cleared Sep 05, 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
K001907 · CGA
Roche Diagnostics Corp.
Chemistry · 75d
Cleared Sep 05, 2000
INVIDOS
K002051 · IYE
Scanditronix Medical AB
Radiology · 61d
Cleared Sep 05, 2000
LINEZOLID, 30UG, BBL SENSI-DISC
K002165 · JTN
Dickinson, and Co.
Microbiology · 49d
Cleared Sep 05, 2000
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
K002380 · FRN
Baxter Healthcare Corp
General Hospital · 32d
Cleared Sep 05, 2000
OBC-63 MEBREAST ARRAY COIL
K002602 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Sep 05, 2000
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K002609 · DHR
Roche Diagnostics Corp.
Immunology · 14d
Cleared Sep 05, 2000
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
K993675 · MUJ
Nomos Corp.
Radiology · 309d
Cleared Sep 05, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994103 · ITX
Olympus America, Inc.
Radiology · 274d
Cleared Sep 01, 2000
STRATO X
K002432 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 24d
Cleared Sep 01, 2000
FENNING HIP STEM
K002441 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 23d