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
140785–140808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1987
BICARBONATE PROCEDURE
K870062 · KHS
Data Medical Associates, Inc.
Chemistry · 37d
Cleared Feb 13, 1987
PANORAMIC X-RAY MODEL PC-1000
K870236 · EHD
Panoramic Corp.
Radiology · 23d
Cleared Feb 13, 1987
CAT EPITHELIUM ALLERGEN DISC
K870264 · DHB
Incstar Corp.
Immunology · 21d
Cleared Feb 13, 1987
ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202
K870329 · HTR
Biodynamic Technologies, Inc.
General & Plastic Surgery · 16d
Cleared Feb 13, 1987
BIODYNAMICS SMALL JOINT BRUSH #1203
K870333 · HTR
Biodynamic Technologies, Inc.
General & Plastic Surgery · 16d
Cleared Feb 13, 1987
P4802 BEA
K870339 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 16d
Cleared Feb 13, 1987
Z2017, BEA/CNA 5%SB BIPLATE
K870340 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 16d
Cleared Feb 13, 1987
P1012 BE AGAR
K870341 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 16d
Cleared Feb 13, 1987
P3700 COL. CNA W/5% SB
K870342 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 16d
Cleared Feb 13, 1987
BIODYNAMICS FEMORAL CANAL BRUSH #1201
K870349 · HTR
Biodynamic Technologies, Inc.
General & Plastic Surgery · 16d
Cleared Feb 13, 1987
COLORED CASTING TAPE (RED AND BLUE)
K870404 · LGF
Buckman Co., Inc.
Orthopedic · 10d
Cleared Feb 13, 1987
EXTENSION/OSCILLATOR TABLE
K870427 · JFB
Heidelberg Medical Products
Physical Medicine · 10d
Cleared Feb 13, 1987
STAT-STAND(TM) AND STAT-STAND II(TM)
K870473 · FOX
I.V. League Medical
General Hospital · 10d
Cleared Feb 12, 1987
KEYMED FIBERSCOPE AUTO DISINFECTOR
K861821 · NVE
Keymed, Inc.
General Hospital · 276d
Cleared Feb 12, 1987
CYTOSTATIC FILTRATION SET
K863218 · LFK
Meadox Surgimed, Inc.
Gastroenterology & Urology · 176d
Cleared Feb 12, 1987
ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST
K864104 · DHB
3M Company
Immunology · 114d
Cleared Feb 12, 1987
FIXTECTOR
K864572 · EFH
Prodent Intl., Inc.
Dental · 84d
Cleared Feb 12, 1987
CHISEL (OSTEOTOME, GOUGE, ETC.)
K864775 · EMM
New England Surgical Instrument Corp.
Dental · 69d
Cleared Feb 12, 1987
DART DIGOXIN ASSAY
K864802 · LCS
Coulter Electronics, Inc.
Chemistry · 65d
Cleared Feb 12, 1987
RAICHEM (TM)SERUM IRON AND TIBC REAGENTS
K864819 · JIY
Reagents Applications, Inc.
Chemistry · 65d
Cleared Feb 12, 1987
THUMBSHELPER POWER RING
K864870 · LQX
Levolon Company, Inc.
Dental · 62d
Cleared Feb 12, 1987
FOREMOST DENTIN ADHESIVE
K864898 · EMA
Foremost Dental Mfg., Inc.
Dental · 59d
Cleared Feb 12, 1987
OBF MODEL 112 VACUUM CUP SYSTEM
K864959 · HKX
Ocular Blood Flow Laboratories, Inc.
Ophthalmic · 56d
Cleared Feb 12, 1987
RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)
K864992 · JFY
Reagents Applications, Inc.
Chemistry · 52d