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
139177–139200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1987
SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.
K871600 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 61d
Cleared Jun 24, 1987
WALLACH CONVERTIBLE COLPOSCOPE
K871682 · HEX
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 56d
Cleared Jun 24, 1987
MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER
K871718 · DSK
A&D Engineering, Inc.
Cardiovascular · 51d
Cleared Jun 24, 1987
COMFORTWEIGH
K871771 · FRW
Curlington Industrial Electronics, Inc.
General Hospital · 49d
Cleared Jun 24, 1987
STAT-VAC CHEST DRAINAGE SYSTEM
K871775 · DTN
Gish Biomedical, Inc.
Cardiovascular · 49d
Cleared Jun 24, 1987
THREE FLUID I.V. SETS
K871841 · FPA
Panamedix, Inc.
General Hospital · 43d
Cleared Jun 24, 1987
TWO FLUID I.V. SETS
K871842 · FPA
Panamedix, Inc.
General Hospital · 43d
Cleared Jun 24, 1987
PB240 PATIENT MONITOR/PULSE OXIMETER
K871864 · DQA
Puritan Bennett Corp.
Anesthesiology · 42d
Cleared Jun 24, 1987
FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM)
K871944 · DSH
Futurecare Systems, Inc.
Cardiovascular · 36d
Cleared Jun 24, 1987
MODIFIED PACE*AID MODEL 53
K871971 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 34d
Cleared Jun 24, 1987
MODEL 5600B PROGRAMMER, PACEMAKER
K871986 · KRG
Telectronics, Inc.
Cardiovascular · 33d
Cleared Jun 24, 1987
GROSHONG CV CATHETER REPAIR KIT
K871998 · LJS
Catheter Technology Corp.
General Hospital · 29d
Cleared Jun 24, 1987
KOTEX STICK TAMPONS, REGULAR AND SUPER
K872018 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 29d
Cleared Jun 24, 1987
MACCONKEY W/SORBITOL
K872188 · JSI
Remel Co.
Microbiology · 16d
Cleared Jun 24, 1987
NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
K872190 · JGS
Nova Biomedical Corp.
Chemistry · 16d
Cleared Jun 23, 1987
HEMOREST(TM)
K864470 · LRL
Health Aid Products
Gastroenterology & Urology · 223d
Cleared Jun 23, 1987
CUSA SYSTEM 200 MACRO-DISSECTOR
K864983 · LFL
Cooper Lasersonics, Inc.
General & Plastic Surgery · 183d
Cleared Jun 23, 1987
NOCTURNAL PENILE TUMESCENCE MONITOR
K870983 · LIL
Texas Medical Electronics Co.
Gastroenterology & Urology · 105d
Cleared Jun 23, 1987
TRUETECH MEDICAL, INC. DENTURE CUPS
K871160 · ELM
Zenex Medical, Inc.
Dental · 91d
Cleared Jun 23, 1987
HPS II CALCAR FEMORAL PROSTHESIS
K871857 · JDI
Depuy, Inc.
Orthopedic · 41d
Cleared Jun 23, 1987
HI MARC INTERLOCKING NAIL
K871872 · HSB
Depuy, Inc.
Orthopedic · 41d
Cleared Jun 23, 1987
KCK INDUSTRIES' SURGICAL INSTRUMENTS
K871894 · GDX
Kck Industries
General & Plastic Surgery · 53d
Cleared Jun 23, 1987
MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT
K871956 · KWA
Downs Surgical , Ltd.
Orthopedic · 34d
Cleared Jun 23, 1987
KINDERWRAP
K872003 · GAX
The Kinder Co.
General & Plastic Surgery · 28d