FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
131209–131232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1989
SR1 (FSH) IMMUNOENZYMETRIC ASSAY
K892706 · CGJ
Serono-Baker Diagnostics, Inc.
Chemistry · 56d
Cleared Jun 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892741 · LYY
Dmacs Intl. Corp.
General Hospital · 59d
Cleared Jun 09, 1989
PATIENT EXAMINATION GLOVES
K893056 · LYY
Hope Rubber Industrial Corp.
General Hospital · 57d
Cleared Jun 09, 1989
PLYMOUTH & LAWANA EXAM GLOVES
K893149 · LYY
Healthgard Medical Products Ltd....
General Hospital · 26d
Cleared Jun 09, 1989
REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181
K893223 · JHO
Helena Laboratories
Chemistry · 43d
Cleared Jun 09, 1989
TRU TRAC TRACTION TABLE
K893448 · ITH
Tru-Trac
Physical Medicine · 37d
Cleared Jun 09, 1989
COMMUNI-CALL
K893473 · ILQ
Carepartners, Inc.
Physical Medicine · 36d
Cleared Jun 08, 1989
EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010
K883865 · CBK
Acutronic Medical Systems AG
Anesthesiology · 268d
Cleared Jun 08, 1989
STAR SYNC
K884521 · CBK
Infrasonics Corp.
Anesthesiology · 224d
Cleared Jun 08, 1989
RESPITRAK
K884959 · BZK
Non-Invasive Monitoring Systems, Inc.
Anesthesiology · 191d
Cleared Jun 08, 1989
EXTENSION SET W/FLOW REGULATOR
K890489 · FPA
Baxter Healthcare Corp
General Hospital · 128d
Cleared Jun 08, 1989
MEDSURG EPIDURAL TRAY 19 GAGE/ECON/BULLET TIP 1000
K890730 · CAZ
Medsurg Industries, Inc.
Anesthesiology · 115d
Cleared Jun 08, 1989
DATA EXCHANGE SYSTEM, MODEL 24
K890921 · CBK
Siemens Life Support Systems
Anesthesiology · 104d
Cleared Jun 08, 1989
PLAYTEX PORTABLES NON-DEODORANT & DOED. TAMPONS
K891297 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 87d
Cleared Jun 08, 1989
CTI II STRAIGHT STEM
K891539 · LWJ
Orthopedic Systems, Inc.
Orthopedic · 83d
Cleared Jun 08, 1989
S 22 INSTRUMENT STAND
K891584 · HRM
Carl Zeiss, Inc.
General & Plastic Surgery · 80d
Cleared Jun 08, 1989
DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800
K891753 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 08, 1989
DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K
K891755 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 08, 1989
CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER
K891997 · HFM
Corometrics Medical Systems, Inc.
Obstetrics & Gynecology · 72d
Cleared Jun 08, 1989
RUBELLA-CUBE(TM)
K892051 · LFX
Difco Laboratories, Inc.
Microbiology · 71d
Cleared Jun 08, 1989
SURGICAL LATEX STERILE GLOVES
K892056 · KGO
Modern Rubber Industrial Co., Ltd.
General Hospital · 76d
Cleared Jun 08, 1989
SITE PHACO PLUS INFUSION SLEEVE
K892852 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 51d
Cleared Jun 08, 1989
QUINTON SINGLE LUMEN CATHETER
K893188 · MPB
Quinton, Inc.
Gastroenterology & Urology · 34d
Cleared Jun 08, 1989
DELCLAMP
K893231 · KDJ
Delmed, Inc.
Gastroenterology & Urology · 41d