FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
9769–9792 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 05, 1996
DIB INFUSOR-RA
K960318 · MEB
Novacon Corp.
General Hospital · 195d
Cleared Aug 01, 1996
SHARPS SAFE 1.5 & SHARPS SAFE 2.0
K955514 · MMK
Dura-Vac Products
General Hospital · 241d
Cleared Aug 01, 1996
FLUID ADMINISTRATION SET - CONTRAST MANAGER
K961794 · FPA
Merit Medical Systems, Inc.
General Hospital · 84d
Cleared Aug 01, 1996
HARE MODEL 2000 EZ LOADER MODEL 95555
K962181 · FPO
Dyna Corp.
General Hospital · 56d
Cleared Jul 30, 1996
ISOLETTE INFANT INCUBATOR
K960980 · FMZ
Air-Shields, Inc.
General Hospital · 141d
Cleared Jul 29, 1996
POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT...
K960225 · LYY
Tillotson Healthcare Corp.
General Hospital · 194d
Cleared Jul 29, 1996
ULTRA CARE POWDER FREE HYPOALLERGENIC PATIENT EXAMINATION GLOVE
K960247 · LYY
Tillotson Healthcare Corp.
General Hospital · 195d
Cleared Jul 26, 1996
PATIENT EXAMINATION GLOVE (POWDERED)
K954293 · LYY
Medline Products Co. , Ltd.
General Hospital · 316d
Cleared Jul 26, 1996
ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
K961287 · KDQ
Rocket Medical Plc
General Hospital · 114d
Cleared Jul 26, 1996
COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962188 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 50d
Cleared Jul 26, 1996
COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962189 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 50d
Cleared Jul 26, 1996
TAKI DISPOSABLE ACUPUNCTURE NEEDLE
K962787 · MQX
Acupuncture Supplies Import Co.
General Hospital · 9d
Cleared Jul 25, 1996
MEDCOMP P-CATH
K953811 · FOZ
Medcomp
General Hospital · 365d
Cleared Jul 25, 1996
PISTON SYRINGE
K955606 · FMF
Medical Surgical Intl.
General Hospital · 230d
Cleared Jul 25, 1996
VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
K960833 · FRA
Uv Technologies, Inc.
General Hospital · 147d
Cleared Jul 25, 1996
BODILY FLUID DISPOSAL KIT
K961217 · FXX
Transidyne General Corp.
General Hospital · 119d
Cleared Jul 25, 1996
AMMI MAGNI-GUARD
K961454 · LYU
American Medical Mfg., Inc.
General Hospital · 101d
Cleared Jul 25, 1996
BG PATIENT EXAMINATION GLOVES, NON-STERILE
K961675 · LYY
Biografik (Malaysia) Sdn Bhd
General Hospital · 90d
Cleared Jul 25, 1996
CW-DISPOSABLE ACUPUNCTURE NEEDLE
K962419 · MQX
Acupuncture Supplies Import Co.
General Hospital · 31d
Cleared Jul 22, 1996
PORT-A-POLE
K961470 · FOX
Prins Medical Ind., Inc.
General Hospital · 96d
Cleared Jul 22, 1996
MUCUS SPECIMEN TRAP
K962168 · KDQ
Sage Products, Inc.
General Hospital · 47d
Cleared Jul 19, 1996
LOW PROFILE TITANIUM PORT DETACHED CATHETER SYSTEM CATALOG #1037
K961615 · LJT
Arrow Intl., Inc.
General Hospital · 84d
Cleared Jul 19, 1996
LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017
K961652 · LJT
Arrow Intl., Inc.
General Hospital · 80d
Cleared Jul 19, 1996
MEDCARE SUCTION CONNECTING TUBING
K961880 · GCX
Medcare Medical Group, Inc.
General Hospital · 65d