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
156409–156432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1983
SPIROMETRICS BREON 2400 & SMI 2400
K831497 · BZG
Spirometrics, Inc.
Anesthesiology · 45d
Cleared Jun 24, 1983
MALIS CMC-II BIPOLAR COAGULATOR & CUT
K831508 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 44d
Cleared Jun 24, 1983
ADJUSTABLE POLYCENTRIC ELBOW HINGE
K831542 · IQI
Fred Sammons, Inc.
Physical Medicine · 43d
Cleared Jun 24, 1983
ADJUST. WEIGHTS-BK5171-05,10,20 BEOK
K831543 · ION
Fred Sammons, Inc.
Physical Medicine · 43d
Cleared Jun 24, 1983
DELUXE TRACTION EXERCISE GLOVE BK5035
K831544 · IOD
Fred Sammons, Inc.
Physical Medicine · 43d
Cleared Jun 24, 1983
FINGER BONIOMETER BK7506
K831550 · KQW
Fred Sammons, Inc.
Neurology · 43d
Cleared Jun 24, 1983
GF-180-L HOLLOW FIBER HEMODIALYSIS
K831606 · KOC
Gambro, Inc.
Gastroenterology & Urology · 37d
Cleared Jun 24, 1983
P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR
K831678 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 32d
Cleared Jun 24, 1983
IPOS ANTI-ADDUCTUS SHOE
K831690 · KNP
Ipos Luneburg
Physical Medicine · 31d
Cleared Jun 24, 1983
SATO FAMILY FIRST AID KIT
K831706 · ILI
Food and Drug Service, Inc.
Physical Medicine · 29d
Cleared Jun 24, 1983
CAPD - CATHETER ADAPTER
K831716 · FKX
American Mcgaw
Gastroenterology & Urology · 28d
Cleared Jun 24, 1983
SITZ BATH, SINGLE PATIENT USE #8100
K831762 · KTC
Lsl Industries, Inc.
Physical Medicine · 23d
Cleared Jun 24, 1983
MODEL GAMMACELL 1000
K837346 · MOT
Atomic Energy of Canada
Radiology · 100d
Cleared Jun 24, 1983
LINEAR ACCELERATOR THERAC 25
K837347 · IYE
Atomic Energy of Canada
Radiology · 81d
Cleared Jun 24, 1983
BF24 DOPPLER MODEL P872 AND P874
K837481
Medasonics, Inc.
Radiology · 46d
Cleared Jun 22, 1983
MARK I & II TOTAL KNEE REPLACE. SYS
K830726 · MBV
Advanced Biosearch Assn.
Orthopedic · 106d
Cleared Jun 22, 1983
RESUSCITAIRE
K830748 · FMT
Vickers America Medical Corp.
General Hospital · 105d
Cleared Jun 22, 1983
UNIVERSAL MEDDARS SYSTEM
K830791 · DPS
Electronics For Medicine, Inc.
Cardiovascular · 100d
Cleared Jun 22, 1983
GOULD MODEL IM3000-IM3100 BATTERY POWER
K830885 · DRT
Gould, Inc.
Cardiovascular · 93d
Cleared Jun 22, 1983
MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION
K830953 · GQL
Syva Co.
Microbiology · 89d
Cleared Jun 22, 1983
INDIRECT FLUORESCENT ANTIBODY REAGENTS
K831026 · LHL
Zeus Technologies
Microbiology · 84d
Cleared Jun 22, 1983
BLOOD GAS & FLAME PHOTOMETER INSTRU-
K831075 · CGC
United Diagnostics, Inc.
Chemistry · 79d
Cleared Jun 22, 1983
EVENT-TEST SLIDE
K831383 · JHJ
Icl Scientific
Chemistry · 55d
Cleared Jun 22, 1983
SURGITEK NEPHROSTENT KIT
K831446 · FAD
Mec/Surgitek Products
Gastroenterology & Urology · 48d