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
148609–148632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 1985
AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA
K851262 · HLI
American Medical Optics
Ophthalmic · 33d
Cleared Apr 30, 1985
SANDARE IRON PROCEDURE
K851394 · JIY
Sandare Chemical Co., Inc.
Chemistry · 21d
Cleared Apr 30, 1985
OVERSHOES (SURCHAUSSURES
K851554 · FXP
Roseburg SA
General Hospital · 14d
Cleared Apr 30, 1985
OP-FACE MASK(MASQUE DE CHIRUGIE)
K851556 · FXX
Roseburg SA
General Hospital · 14d
Cleared Apr 30, 1985
SURGICAL CAP CALOT
K851558 · FYF
Roseburg SA
General & Plastic Surgery · 14d
Cleared Apr 30, 1985
TURQUOISE
K851559 · FYA
Roseburg SA
General Hospital · 14d
Cleared Apr 30, 1985
LEVINE EMB AGAR
K851584 · JSI
Preferred Micro-Media
Microbiology · 14d
Cleared Apr 30, 1985
MANNITOL SALT AGAR
K851585 · JSI
Preferred Micro-Media
Microbiology · 14d
Cleared Apr 30, 1985
MACCONKEY AGAR
K851586 · JSI
Preferred Micro-Media
Microbiology · 14d
Cleared Apr 30, 1985
THAYER MARTIN AGAR & MODIFIED THAYER AGAR
K851587 · JTY
Preferred Micro-Media
Microbiology · 14d
Cleared Apr 30, 1985
CHOCOLATE AGAR
K851588 · KZI
Preferred Micro-Media
Microbiology · 14d
Cleared Apr 30, 1985
MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE
K851589 · JTZ
Preferred Micro-Media
Microbiology · 14d
Cleared Apr 30, 1985
MYCOLOGY AGAR W/ANTIBOTICS
K851590 · JSJ
Preferred Micro-Media
Microbiology · 14d
Cleared Apr 29, 1985
DSL PAP RIA -DSL#3100
K844679 · JFH
Diagnostic Systems Laboratories, Inc.
Chemistry · 150d
Cleared Apr 29, 1985
PTH-RIA
K844735 · CEW
Syncor Intl. Corp.
Chemistry · 146d
Cleared Apr 29, 1985
POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE
K844803 · DTP
Electromedics, Inc.
Cardiovascular · 139d
Cleared Apr 29, 1985
JMS NEEDLES & JMS SYRINGES
K845043 · FMI
Jms Co., Ltd.
General Hospital · 122d
Cleared Apr 29, 1985
UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL
K850029 · BXX
Utah Medical Products, Inc.
Anesthesiology · 115d
Cleared Apr 29, 1985
INTRACARDIAC SUMP 12010
K850385 · DWF
Dlp, Inc.
Cardiovascular · 87d
Cleared Apr 29, 1985
NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-1050
K850476 · DXN
Unisonic Products Corp.
Cardiovascular · 90d
Cleared Apr 29, 1985
NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-2050
K850477 · DXN
Unisonic Products Corp.
Cardiovascular · 90d
Cleared Apr 29, 1985
ARCEE DENTAL POST
K851038 · ELR
Arcee Dental Products Co.
Dental · 46d
Cleared Apr 29, 1985
SUGAR-CHEX
K851042 · JJX
Streck Laboratories, Inc.
Chemistry · 46d
Cleared Apr 29, 1985
SUGAR-CHEX II
K851043 · JJX
Streck Laboratories, Inc.
Chemistry · 46d