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
145345–145368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1986
BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO
K853629 · FRN
C.R. Bard, Inc.
General Hospital · 150d
Cleared Jan 27, 1986
CUSTO PORT 24-H ECG AMBULATORY RECORDER
K854115 · DSI
Versacor, Inc.
Cardiovascular · 111d
Cleared Jan 27, 1986
PULSE LAVAGE
K854543 · FQH
Tava Surgical Instruments
General Hospital · 75d
Cleared Jan 27, 1986
CHURCHILL - HBC VENTED BALL CHECK IV SET
K854658 · FPA
Churchill Corp.
General Hospital · 68d
Cleared Jan 27, 1986
MICROSCOPE COLUMN DRAPE
K860067
O.R. Concepts, Inc.
General & Plastic Surgery · 21d
Cleared Jan 27, 1986
FOOT PEDAL COVER
K860068
O.R. Concepts, Inc.
General & Plastic Surgery · 21d
Cleared Jan 27, 1986
HOLD-IT FRAMED ADHESIVE FILM
K860071 · KMK
Vlv Associates, Inc.
General Hospital · 21d
Cleared Jan 27, 1986
LARYNGECTOMY TUBE, CUFFED
K860176 · BTO
Sheridan Catheter Corp.
Anesthesiology · 10d
Cleared Jan 24, 1986
TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA
K853029 · GKZ
Technicon Instruments Corp.
Hematology · 190d
Cleared Jan 24, 1986
MODEL XA-50 - CO2 SURGICAL LASER
K853620 · GEX
Xanar, Inc.
General & Plastic Surgery · 148d
Cleared Jan 24, 1986
CAMERON-MILLER MODEL 80-2701, BIPOLAR COAGULATOR
K853972 · GEI
Cameron-Miller, Inc.
General & Plastic Surgery · 120d
Cleared Jan 24, 1986
ELECTROSURGICAL DEVICES, 26-0330,26-335,340 & 0345
K854109 · GEI
Cameron-Miller, Inc.
General & Plastic Surgery · 108d
Cleared Jan 24, 1986
MEDSURG AMNIOCENTESIS TRAY
K854290
Medsurg Industries, Inc.
Obstetrics & Gynecology · 91d
Cleared Jan 24, 1986
TDX C-REACTIVE PROTEIN
K854542 · DCK
Abbott Laboratories
Immunology · 72d
Cleared Jan 24, 1986
LM 1000
K854767 · GEH
Leisegang Medical, Inc.
General & Plastic Surgery · 58d
Cleared Jan 24, 1986
ICS PAB PREALBUMIN REAGENT TEST KIT
K854811 · DDS
Beckman Instruments, Inc.
Immunology · 52d
Cleared Jan 24, 1986
APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1
K854875 · DER
Photec Diagnostics, Inc.
Immunology · 51d
Cleared Jan 24, 1986
PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE)
K854905 · GBO
Angiomed U.S., Inc.
General & Plastic Surgery · 46d
Cleared Jan 24, 1986
PERCUTANEOUS NEPHROSTOMY SETS (OTTO)
K854906 · GBO
Angiomed U.S., Inc.
General & Plastic Surgery
Cleared Jan 24, 1986
PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)
K854907 · GBO
Angiomed U.S., Inc.
General & Plastic Surgery · 46d
Cleared Jan 24, 1986
PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS
K854909 · GBO
Angiomed U.S., Inc.
General & Plastic Surgery · 46d
Cleared Jan 24, 1986
PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER)
K854911 · GBO
Angiomed U.S., Inc.
General & Plastic Surgery · 46d
Cleared Jan 24, 1986
MOBIN-VDDIN VEIN GRAFT HOLDER
K854913
Pilling Co.
General & Plastic Surgery · 46d
Cleared Jan 24, 1986
PILLING IDENTILOOPS
K854914
Pilling Co.
General & Plastic Surgery · 46d