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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
120481–120504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 22, 1991
ADVANTAGE EP
K903734 · GWE
Clark Davis Medical Systems, Inc.
Neurology · 340d
Cleared Jul 22, 1991
BELSCOPE LARYNGOSCOPE
K904918 · CCW
Avulunga Pty. , Ltd.
Anesthesiology · 264d
Cleared Jul 22, 1991
HYPERLITE
K905168 · CBF
S.O.S. , Ltd.
Anesthesiology · 248d
Cleared Jul 22, 1991
UNIQUANT
K905435 · GWQ
Neuroconcepts, Inc.
Neurology · 230d
Cleared Jul 22, 1991
HUMAN C-REACTIVE PROTEIN RID KIT
K905633 · DCK
The Binding Site, Ltd.
Immunology · 220d
Cleared Jul 22, 1991
ARGON BEAM COMBO LAPAROSCOPIC ELECTRODE
K905752 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 210d
Cleared Jul 22, 1991
GENESYS AND THE ROI
K910002 · JAI
The Complete Systems Corp. Genesys
Radiology · 201d
Cleared Jul 22, 1991
FETALGARD 2000
K910169 · HGM
Analogic Corp.
Obstetrics & Gynecology · 188d
Cleared Jul 22, 1991
THERAPY CHAIR SYSTEM
K910648 · JAI
Radiation Technology, Inc.
Radiology · 158d
Cleared Jul 22, 1991
SURGICAL GLOVES
K910895 · KGO
Influx Pacific Sdn. Bhd.
General Hospital · 140d
Cleared Jul 22, 1991
INFUSABLE
K911216 · KZD
Biomedical Dynamics, Inc.
General Hospital · 125d