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
112441–112464 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1993
UNIVERSAL IRRIGATION & SUCTION TUBING SET
K922714 · JOL
Ximed Medical Systems
General Hospital · 424d
Cleared Aug 03, 1993
PATIENT EXAMINATION GLOVE
K924556 · LYY
Cenland Industries Sdn Bhd
General Hospital · 328d
Cleared Aug 03, 1993
BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET
K925058 · FPA
C.R. Bard, Inc.
General Hospital · 301d
Cleared Aug 03, 1993
LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER
K925430 · FPA
Douglas Medical Products Corp.
General Hospital · 280d
Cleared Aug 03, 1993
OPHTHALMOSCOPE
K925757 · HLJ
Rudolf Riester GmbH & Co. KG
Ophthalmic · 263d
Cleared Aug 03, 1993
OTOSCOPE
K925758 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 263d
Cleared Aug 03, 1993
NEURO-CARE 1000
K926265 · IPF
Ems Northwest
Physical Medicine · 228d
Cleared Aug 03, 1993
ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT
K930188 · JWH
Dow Corning Wright
Orthopedic · 201d
Cleared Aug 03, 1993
REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278
K930317 · CEF
Helena Laboratories
Chemistry · 193d
Cleared Aug 03, 1993
SYNELISA PARIETAL CELL ANTIBODIES
K930422 · DBJ
Elias U.S.A., Inc.
Immunology · 189d
Cleared Aug 03, 1993
ABUSCREEN ONLINE(R) CALIBRATORS
K931124 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 152d
Cleared Aug 03, 1993
ABUSCREEN ONLINE CONTROL
K931125 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 152d
Cleared Aug 03, 1993
BICARBONATE
K931887 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 110d
Cleared Aug 03, 1993
MARKSMAN ARTERIAL BLOOD GAS SYRINGE
K931924 · JKA
Martech Medical Products, Inc.
Chemistry · 109d
Cleared Aug 03, 1993
MAXIMA FILTERED HARDSHELL RESERVOIR
K932254 · DTB
Medtronic Vascular
Cardiovascular · 85d
Cleared Aug 03, 1993
9150A, 1100F
K932355 · IZL
Dynarad Corp.
Radiology · 82d
Cleared Aug 03, 1993
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS)
K932729 · CEO
Eastman Kodak Company
Chemistry · 57d
Cleared Aug 03, 1993
DELFIA TESTTOSTERONE KIT
K932951 · CDZ
Wallac OY
Chemistry · 47d
Cleared Aug 02, 1993
PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
K905663 · DSP
Datascope Corp.
Cardiovascular · 958d
Cleared Aug 02, 1993
PRIVATE LABELS AND FEMTEX
K920238 · HEB
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 563d
Cleared Aug 02, 1993
SHARPLAN 2100,3000,SHARPLASER 65, 40
K920865 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 524d
Cleared Aug 02, 1993
RUSCH SAFETY CLEAR UNCUFFED WITH MURPHY EYE
K925506 · BTR
Rusch, Inc.
Anesthesiology · 276d
Cleared Aug 02, 1993
DISPOSABLE SCLERAL PLUGS
K925671 · LXP
O.R. Specialties, Inc.
Ophthalmic · 265d
Cleared Aug 02, 1993
O'BRIEN GONIOMETER
K926237 · KQW
Sgarlato Laboratories, Inc.
Neurology · 234d