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: General Hospital ×
17,766 results
15553–15576 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 21, 1985
PAD, PRE-OPERATIVE PREPARATION
K850811 · KME
East Texas Lighthouse For the Blind
General Hospital · 21d
Cleared Mar 13, 1985
CATH-TECH POLYURETHANE UMBILICAL VESS
K842577 · FOZ
Catheter Technology Corp.
General Hospital · 253d
Cleared Mar 13, 1985
IV ADMIN. SET FOR MVP 1 INFUSION PUMP
K843311 · FRN
Ziehm International, Inc.
General Hospital · 202d
Cleared Mar 13, 1985
CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M
K850183 · FRN
Deltec Systems, Inc.
General Hospital · 54d
Cleared Mar 12, 1985
REPRO-MED SYSTEMS INFUSION DEVICE
K844401 · FRN
Repro-Med Systems, Inc.
General Hospital · 119d
Cleared Mar 12, 1985
PLURA-GARD CHEST DRAINAGE SYSTEM
K844942 · KDQ
Consolidated Medical Equipment, Inc.
General Hospital · 82d
Cleared Mar 12, 1985
KARECO INT'L - DOUGLE-HOOK I.V. STAND
K845031 · FOX
Kareco Intl., Inc.
General Hospital · 75d
Cleared Mar 12, 1985
SPECIAL PROCEDURES PACK
K850339 · FPA
Marwood Medical, Inc.
General Hospital · 43d
Cleared Mar 12, 1985
SHAVE PREP TRAY
K850544 · KME
Packaging Technologies, Inc.
General Hospital · 28d
Cleared Mar 11, 1985
IMPACT 901 SERIES PORT-A-WALL
K850671 · FOX
Impact Instrumentation, Inc.
General Hospital · 19d
Cleared Mar 07, 1985
CRITIKON I.V. ADMINISTRAION SET
K850507 · FPA
Critikon Company, LLC
General Hospital · 27d
Cleared Mar 06, 1985
IMED 980 VOLUMETRIC INFUSION PUMP
K844915 · FRN
Imed Corp.
General Hospital · 78d
Cleared Mar 06, 1985
VERSA-FILL 120 & FILL SET 42-50
K850051 · LHI
Intl. Medical Industries
General Hospital · 57d
Cleared Mar 06, 1985
KM PRODUCTS SUCTION TIPS
K850240 · JOL
Km Products
General Hospital · 43d
Cleared Mar 04, 1985
HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR
K844201 · FLL
Mallinckrodt Critical Care
General Hospital · 125d
Cleared Mar 04, 1985
SUCTION REGULATOR 7700 SERIES
K850200 · KDP
Boehringer Laboratories
General Hospital · 45d
Cleared Mar 01, 1985
RICO RS4-XP EMERGENCY MEDICAL ASPIRATOR
K844881 · GCX
Rico Suction Laboratories, Inc.
General Hospital · 74d
Cleared Mar 01, 1985
RICO RS-6X EMERGENCY MEDICAL ASPIRATOR
K844882 · GCX
Rico Suction Laboratories, Inc.
General Hospital · 74d
Cleared Feb 27, 1985
XANAR MODEL XSE-300 SMOKE EVACULATER
K844087 · FYD
Xanar, Inc.
General Hospital · 128d
Cleared Feb 26, 1985
STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH
K850326 · KKX
Excel Health Care Products
General Hospital · 29d
Cleared Feb 26, 1985
PALL GAS LINE GUARDIAN FILTER
K850327 · CAH
Pall Biomedical Products Co.
General Hospital · 29d
Cleared Feb 22, 1985
INSTRUTAINER
K844672 · FRG
Intrumed, Inc.
General Hospital · 84d
Cleared Feb 22, 1985
CYTOSAFE NEEDLE
K844904 · LHI
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 67d
Cleared Feb 22, 1985
SILVER SPOON ENTERAL FEEDING PUMP
K850098 · FRN
Sterling Medical Devices, Inc.
General Hospital · 42d