FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79657–79680 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 2001
ETEST MEROPENEM
K010363 · JWY
Ab Biodisk
Microbiology · 61d
Cleared Apr 09, 2001
ATAC PAK AST REAGENT KIT
K010488 · CIT
Elan Holdings, Inc.
Chemistry · 48d
Cleared Apr 09, 2001
KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP
K010569 · GCJ
Karl Storz Endoscopy
General & Plastic Surgery · 42d
Cleared Apr 09, 2001
BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160
K010570 · LNH
Mri Devices Corp.
Radiology · 42d
Cleared Apr 09, 2001
POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K010671 · LYZ
Tong Ruhn Medical Products Co., Ltd.
General Hospital · 34d
Cleared Apr 09, 2001
POWDER FREE TEXTURED VINYL EXAMINATION GLOVES
K010830 · LYZ
General Gloves Corp.
General Hospital · 20d
Cleared Apr 09, 2001
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K010909 · GAW
Tyco Healthcare Group LP
General & Plastic Surgery · 14d
Cleared Apr 09, 2001
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
K010931 · OTO
American Medical Systems, Inc.
Obstetrics & Gynecology · 12d
Cleared Apr 06, 2001
TCOYF FERTILITY SOFTWARE VERSION 1.0
K002726 · LHD
Ovusoft, LLC
Obstetrics & Gynecology · 218d
Cleared Apr 06, 2001
PNS MAGNETIC STIMULATOR SYSTEM
K002889 · KOI
Neotonus, Inc.
Anesthesiology · 203d
Cleared Apr 06, 2001
LPC-PLUS ACETABULAR CUP
K003274 · LZO
Plus Orthopedics
Orthopedic · 170d
Cleared Apr 06, 2001
PREAMP CABLE, MODEL B400-1011PA
K003542 · DQA
Beta Biomed Services, Inc.
Anesthesiology · 140d
Cleared Apr 06, 2001
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K010100 · KRR
Howmedica Osteonics Corp.
Orthopedic · 85d
Cleared Apr 06, 2001
ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
K010124 · KWS
Arthrex, Inc.
Orthopedic · 80d
Cleared Apr 06, 2001
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
K010171 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 78d
Cleared Apr 06, 2001
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES...
K010776 · MNH
Corin USA
Orthopedic · 23d
Cleared Apr 06, 2001
T2 FEMORAL NAIL
K010801 · HSB
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Apr 06, 2001
TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE
K010883 · ITX
Teratech Corp.
Radiology · 14d
Cleared Apr 06, 2001
MODIFICATION TO PLUM XL INFUSION PUMP
K010924 · FRN
Abbott Laboratories
General Hospital · 10d
Cleared Apr 05, 2001
PERIFORM PERINEOMETRIC PROBE, MODEL 8300
K002617 · HIR
Neen Design , Ltd.
Gastroenterology & Urology · 225d
Cleared Apr 05, 2001
FRSENIUS PD IQCARD CYCLER
K002892 · FKX
Fresenius Medical Care North America
Gastroenterology & Urology · 202d
Cleared Apr 05, 2001
HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE...
K003350 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 161d
Cleared Apr 05, 2001
SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)
K003701 · JOW
Sentech Medical Systems, Inc.
Cardiovascular · 125d
Cleared Apr 05, 2001
NUVOLASE 532 MEDICAL LASER SYSTEM
K010046 · GEX
American Laser Corp.
General & Plastic Surgery · 90d