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
152113–152136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 1984
NEUROMEDICS ULTRASTIM 650-01
K841647 · IPF
Intermedics, Inc.
Physical Medicine · 74d
Cleared Jul 03, 1984
FALL-SAFE MONITOR
K841671 · KMI
Fsm Corp.
General Hospital · 71d
Cleared Jul 03, 1984
FALL-SAFE VEST
K841672 · KMI
Fsm Corp.
General Hospital · 71d
Cleared Jul 03, 1984
UTERINE INJECTOR 4.0MM
K841682 · HES
Humi Corp.
Obstetrics & Gynecology · 71d
Cleared Jul 03, 1984
SECURA SET
K841859 · FPA
Diatek, Inc.
General Hospital · 60d
Cleared Jul 03, 1984
DISPOS. POLY APRONS
K842016 · LDQ
Abco Dealers, Inc.
General & Plastic Surgery · 46d
Cleared Jul 03, 1984
SPOTTEST LACTOPHENOL COTTON BLUE STAIN
K842086 · JTO
Difco Laboratories, Inc.
Microbiology · 40d
Cleared Jul 03, 1984
EPIDURAL TRAYS
K842095 · CAZ
Concord Laboratories, Inc.
Anesthesiology · 39d
Cleared Jul 03, 1984
TISCHLER CERVICAL BIOPSY PUNCH FORCEPS
K842112 · HFB
J. Sklar Mfg. Co., Inc.
Obstetrics & Gynecology · 35d
Cleared Jul 03, 1984
LYFO-DISK MICROORGANISMS
K842129 · JTR
Micro-Bio-Logics
Microbiology · 35d
Cleared Jul 03, 1984
SURE & NATURAL MAXI-SHIELD
K842480 · HHD
Johnson & Johnson Professionals, Inc.
Obstetrics & Gynecology · 8d
Cleared Jul 02, 1984
CARDIO EXPRESS 100 HOLTER SCANNER
K840622 · DSI
Del Mar Avionics
Cardiovascular · 139d
Cleared Jul 02, 1984
ACS SOF-T GUIDE WIREE
K840795 · DQT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 130d
Cleared Jul 02, 1984
ARK TONGUE CLEANER
K841077 · LCN
Arkay Co.
Dental · 112d
Cleared Jul 02, 1984
GENERAL DIAGNOSTICS PLATELET ANTIBODY
K841465 · LLG
General Diagnostics
Immunology · 84d
Cleared Jul 02, 1984
STERILE O.R. BASIN KIT PRODUCT LINE
K841484 · FRG
Medline Industries, Inc.
General Hospital · 83d
Cleared Jul 02, 1984
10.5 FRENCH DILATOR, 15CM, W/LUER LOCK
K841995 · DRE
Quinton, Inc.
Cardiovascular · 48d
Cleared Jul 02, 1984
IDI ISOTONIC DILUENT
K842068 · GIF
Interscience Diagnostics, Inc.
Hematology · 40d
Cleared Jul 02, 1984
IDL-LYSING REAGENT
K842069 · GGK
Interscience Diagnostics, Inc.
Hematology · 40d
Cleared Jul 02, 1984
IDD DETERGENT
K842070 · PPM
Interscience Diagnostics, Inc.
Hematology · 40d
Cleared Jul 02, 1984
VENTRESCREEN STREP A TEST
K842239 · GWC
Ventrex Laboratories, Inc.
Microbiology · 27d
Cleared Jul 02, 1984
PATHO DX LATEX AGGLUTINATION STREP A
K842383 · GTZ
Diagnostic Products Corp.
Microbiology · 14d
Cleared Jul 02, 1984
BIOTIS N.Y.C. CARBOHYDRATE FERMENTA-
K842400
Otisville Biotech, Inc.
Microbiology · 13d
Cleared Jul 02, 1984
BIOTIS LD-PRESUMPTO QUADRANT PLATE
K842424 · JSE
Otisville Biotech, Inc.
Microbiology · 12d