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
138001–138024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1987
DIALY-NATE SET & DIALY-NATE CATHETER
K872221 · FKO
Gesco Intl., Inc.
Gastroenterology & Urology · 126d
Cleared Oct 13, 1987
HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
K872364 · FII
Travenol Laboratories, S.A.
Gastroenterology & Urology · 117d
Cleared Oct 13, 1987
4LYF OXYGEN CONCENTRATOR
K872534 · CAW
Airsep Corp.
Anesthesiology · 109d
Cleared Oct 13, 1987
IMSI/EASY FLOAT MATTRESS
K872876 · FOH
Intl. Management Services, Inc.
General Hospital · 84d
Cleared Oct 13, 1987
TRACH CARE START KIT
K873732 · BSY
Ballard Medical Products
Anesthesiology · 64d
Cleared Oct 13, 1987
ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER
K873773 · GEX
Hgm, Inc.
General & Plastic Surgery · 27d
Cleared Oct 13, 1987
INSPIREASE(R), DRUG DELIVERY SYSTEM
K873793 · CCQ
Key Pharmaceuticals, Inc.
Anesthesiology · 26d
Cleared Oct 13, 1987
ALBUMIN IN URINE
K873861 · DCF
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
APOLIPOPROTEIN A1
K873863 · MSJ
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
APOLIPOPROTEIN B
K873864 · MSJ
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
CRP
K873865 · DCK
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
TRANSFERRIN
K873867 · DDG
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
IMMUNOGLOBULINS A
K873869 · CZP
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
IMMUNOGLOBULINS G
K873870 · DEW
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
IMMUNOGLOBULINS M
K873871 · DFT
Unipath , Ltd.
Immunology · 50d
Cleared Oct 09, 1987
SUTTER FINGER JOINT PROSTHESIS
K870200 · KYJ
Sutter Biomedical, Inc.
Orthopedic · 262d
Cleared Oct 09, 1987
NTH 101 UL
K871177 · FMT
Aragona Medical, Inc.
General Hospital · 199d
Cleared Oct 09, 1987
MTC XI UL
K871178 · FMT
Aragona Medical, Inc.
General Hospital · 199d
Cleared Oct 09, 1987
LOW AIR LOSS BED
K871705 · FNM
Integrated Medical Equipment Co.
General Hospital · 161d
Cleared Oct 09, 1987
CHURCHILL TPN ADMINISTRATION SET
K872123 · FPA
Churchill Corp.
General Hospital · 130d
Cleared Oct 09, 1987
BARD EPICARDIAL ELECTRODE ARRAY
K872231 · DRF
C.R. Bard, Inc.
Cardiovascular · 122d
Cleared Oct 09, 1987
SAFEWEIGH MAGIC SCALE
K872524 · FRW
Health Care Innovations, Inc.
General Hospital · 106d
Cleared Oct 09, 1987
ORTHODONTIC ARCH
K872622 · EJZ
Wonder Wire
Dental · 95d
Cleared Oct 09, 1987
BAXA TUBING SETS (FOR PHARMACY PUMP)
K872743 · FMF
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 88d