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
120745–120768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1991
SOFT TISSUE SUTURE WASHER/3 HOLE WASHER
K910229 · HTN
Depuy, Inc.
Orthopedic · 187d
Cleared Jul 24, 1991
BARD REPLACEMENT GASTROSTOMY TUBE
K910492 · KGC
C.R. Bard, Inc.
Gastroenterology & Urology · 169d
Cleared Jul 24, 1991
DC200 DEFIBRILLATOR
K910634 · LDD
Siemens Burdick, Inc.
Cardiovascular · 161d
Cleared Jul 24, 1991
SPINAL TAP NEEDLE
K910652 · BSP
Gesco Intl., Inc.
Anesthesiology · 160d
Cleared Jul 24, 1991
SFA-II MICROPROCESSOR-CONTROLLED MODULE
K910905 · DRQ
Life Sciences Manufacturing, Inc.
Cardiovascular · 141d
Cleared Jul 24, 1991
ICON STREP B IMMUNOENZYMETRIC ASSAY
K911417 · GTZ
Hybritech, Inc.
Microbiology · 114d
Cleared Jul 24, 1991
OLYMPUS PK TP(TM) SYSTEM, MODIFICATION
K911640 · GMT
Olympus Corp.
Microbiology · 107d
Cleared Jul 24, 1991
SALTER LABS NEONATAL NASAL OXYGEN CANNULA
K911740 · CAT
Salter Labs
Anesthesiology · 98d
Cleared Jul 24, 1991
GASPARAITIS ESOPHAGRAM CATHETER SET
K911897 · KNT
E-Z-Em, Inc.
Gastroenterology & Urology · 86d
Cleared Jul 24, 1991
HEPARIN ADSORBENT
K912061 · JPA
Sigma Diagnostics, Inc.
Hematology · 76d
Cleared Jul 24, 1991
SALTER LABS DISPOSABLE NIPPLE AND NUT
K912174 · CAN
Salter Labs
Anesthesiology · 69d
Cleared Jul 24, 1991
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
K912208 · KDJ
Fresenius USA, Inc.
Gastroenterology & Urology · 65d
Cleared Jul 24, 1991
PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT
K912256 · KLE
Lee Pharmaceuticals
Dental · 63d
Cleared Jul 24, 1991
QUIKPAC-II ONE STEP PREGNANCY HOME TEST
K912316 · LCX
Syntron Bioresearch, Inc.
Chemistry · 61d
Cleared Jul 24, 1991
HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT
K912395 · MEH
Howmedica Corp.
Orthopedic · 57d
Cleared Jul 24, 1991
MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA
K912408 · MHI
Meridian Diagnostics, Inc.
Microbiology · 54d
Cleared Jul 24, 1991
ACCU-PLACER TM KIT
K912473 · EKJ
Hu-Friedy Mfg. Co., Inc.
Dental · 50d
Cleared Jul 24, 1991
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912488 · LSE
Immuno Concepts, Inc.
Microbiology · 50d
Cleared Jul 24, 1991
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912489 · LSE
Immuno Concepts, Inc.
Microbiology · 50d
Cleared Jul 24, 1991
SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID
K912665 · ESD
Resound Corp.
Ear, Nose, Throat · 36d
Cleared Jul 24, 1991
COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA
K912940 · JZG
Diagnostic Products Corp.
Immunology · 19d
Cleared Jul 23, 1991
TRIP(TM) NASOGASTRIC SUMP CATHETER
K911825 · FFT
Tonometrics, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 23, 1991
MODEL 5866-9M & MODEL 6981M
K911827 · DTD
Metronic, Inc.
Cardiovascular · 90d
Cleared Jul 23, 1991
PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS
K912542 · KKX
Puritas Health Care, Inc.
General Hospital · 43d