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
141265–141288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 1987
AM CATH ESWL STENT
K864669 · FAD
Inter-Med Corp.
Gastroenterology & Urology · 34d
Cleared Jan 05, 1987
MICRODILUTION IDENTIFICATION PANELS
K864674 · JSE
American Micro Scan
Microbiology · 34d
Cleared Jan 05, 1987
RAICHEM(TM) AMMONIA REAGENT
K864706 · JIF
Reagents Applications, Inc.
Chemistry · 34d
Cleared Jan 05, 1987
CULT-UR
K864727 · LIO
R.P. Laboratories, Inc.
Microbiology · 34d
Cleared Jan 05, 1987
LKB 2260 MACROTOME
K864733 · IDO
Lkb Instruments, Inc.
Pathology · 32d
Cleared Jan 05, 1987
BONE MARROW COLLECTION MEDIUM
K864740 · KIT
Bioclinical Laboratory Services, Inc.
Pathology · 32d
Cleared Jan 05, 1987
PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM
K864755 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 31d
Cleared Jan 05, 1987
S&W MODEL HIGH-LOW MAT TABLE, VARIOUS MODELS
K864817 · INQ
S & W Enterprises, Inc.
Physical Medicine · 27d
Cleared Jan 05, 1987
SUNTANNING LAMP
K864907 · FTC
Interlectric Corp.
General & Plastic Surgery · 21d
Cleared Jan 05, 1987
TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY
K864945 · JFH
Hybritech, Inc.
Chemistry · 19d
Cleared Jan 02, 1987
ULTRASOUND TRANSDUCER ASSEMBLY
K862211 · ITX
Johnson & Johnson Professionals, Inc.
Radiology · 206d
Cleared Jan 02, 1987
MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
K862459 · DXY
Medtronic Vascular
Cardiovascular · 186d
Cleared Jan 02, 1987
VEIN VALVE CUTTER
K862724 · DQY
American Edwards Laboratories
Cardiovascular · 169d
Cleared Jan 02, 1987
2200I PHYSIOLOGICAL MONITOR
K863308 · DXG
Datascope Corp.
Cardiovascular · 130d
Cleared Jan 02, 1987
EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER
K864007 · DXE
Uresil Corp.
Cardiovascular · 79d
Cleared Jan 02, 1987
BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600
K864235 · DTZ
C.R. Bard, Inc.
Cardiovascular · 66d
Cleared Jan 02, 1987
ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING
K864262 · DTM
Johnson & Johnson Professionals, Inc.
Cardiovascular · 65d
Cleared Dec 31, 1986
MAGNESIOMETER
K863069 · JGJ
J. D. Assoc.
Chemistry · 141d
Cleared Dec 31, 1986
DERMATEC TRANSPARENT FILM DRESSING
K863580 · NAD
Dermatec, Inc.
General & Plastic Surgery · 125d
Cleared Dec 31, 1986
SYNCHRON CX3
K864236 · JJF
Beckman Instruments, Inc.
Chemistry · 64d
Cleared Dec 31, 1986
QKO (TM) AMYLASE B-HA
K864303 · JFJ
Wako Chemicals USA, Inc.
Chemistry · 61d
Cleared Dec 31, 1986
AP1 COLORIMETER
K864634 · JJQ
Awareness Technology, Inc.
Chemistry · 36d
Cleared Dec 31, 1986
CHLORIDE REAGENT
K864713 · CHJ
Sigma Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 31, 1986
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
K864715 · CIX
Em Diagnostic Systems, Inc.
Chemistry · 28d